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Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

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ClinicalTrials.gov Identifier: NCT03603106
Recruitment Status : Completed
First Posted : July 27, 2018
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Diagnostic
Conditions Healthy Volunteers
Brain Lesion
Interventions Drug: P03277
Drug: Placebo
Enrollment 142
Recruitment Details  
Pre-assignment Details For part I, all patients who were not randomized were screening failures. For part II, all patients who were not allocated to a dose of P03277 were screening failures.
Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg
Hide Arm/Group Description 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

3 healthy subjects per dose group received placebo in one single administration.

Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
Period Title: Overall Study
Started 6 6 6 6 6 6 18 3 3 3 3
Completed 6 6 6 6 6 6 18 3 3 3 3
Not Completed 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg Total
Hide Arm/Group Description

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

6 subjects received P03277 in one single administration.

P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

3 healthy subjects per dose group received placebo in one single administration.

Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

3 patients received one single administration of P03277.

P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.

3 patients received one single administration of P03277.

P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.

3 patients received one single administration of P03277.

P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.

3 patients received one single administration of P03277.

P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 18 3 3 3 3 66
Hide Baseline Analysis Population Description
All patients who received one injection of product (placebo or P03277 for Part I, P03277 for Part II).
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 3 participants 3 participants 3 participants 3 participants 66 participants
26.0
(22 to 30)
25.5
(21 to 37)
27.5
(23 to 40)
25.5
(23 to 41)
23.0
(18 to 36)
33.5
(23 to 42)
26.5
(19 to 43)
40.0
(37 to 50)
56.0
(25 to 57)
56.0
(53 to 61)
53.0
(50 to 58)
28.0
(18 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 3 participants 3 participants 3 participants 3 participants 66 participants
Female
3
  50.0%
4
  66.7%
3
  50.0%
3
  50.0%
3
  50.0%
3
  50.0%
8
  44.4%
1
  33.3%
2
  66.7%
1
  33.3%
1
  33.3%
32
  48.5%
Male
3
  50.0%
2
  33.3%
3
  50.0%
3
  50.0%
3
  50.0%
3
  50.0%
10
  55.6%
2
  66.7%
1
  33.3%
2
  66.7%
2
  66.7%
34
  51.5%
Weight  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 18 participants 3 participants 3 participants 3 participants 3 participants 66 participants
81.65
(52.2 to 87.4)
71.60
(54.0 to 83.6)
65.00
(56.4 to 93.0)
72.50
(62.0 to 99.2)
69.30
(68.2 to 87.6)
72.50
(61.6 to 88.6)
67.90
(56.8 to 89.4)
87.20
(85.8 to 89.0)
80.40
(71.2 to 87.4)
87.20
(82.4 to 102.8)
85.80
(79.4 to 101.6)
72.85
(52.2 to 102.8)
1.Primary Outcome
Title Pharmacokinetic (PK) Parameter Cmax
Hide Description Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.
Time Frame From baseline (30 minutes before injection) to 24 hours post-injection
Hide Outcome Measure Data
Hide Analysis Population Description

In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).

In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).

Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part II (Phase IIA) 0.05 mmol/kg Part II (Phase IIA) 0.075 mmol/kg Part II (Phase IIA) 0.1 mmol/kg Part II (Phase IIA) 0.2 mmol/kg
Hide Arm/Group Description:
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s.
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s.
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s.
3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
Overall Number of Participants Analyzed 5 6 6 6 6 6 3 3 2 3
Mean (Standard Deviation)
Unit of Measure: µg/mL
248.7  (54.5) 524.5  (69.9) 698.7  (378.9) 992.0  (233.1) 2097.6  (572.3) 3916.4  (1114.8) 370.8  (117.6) 618.2  (439.7) 701.6  (48.5) 1434.9  (651.5)
2.Primary Outcome
Title PK Parameter T1/2
Hide Description T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.
Time Frame From baseline (30 minutes before injection) to 24 hours post-injection
Hide Outcome Measure Data
Hide Analysis Population Description

In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).

In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).

Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part II (Phase IIA) 0.05 mmol/kg Part II (Phase IIA) 0.075 mmol/kg Part II (Phase IIA) 0.1 mmol/kg Part II (Phase IIA) 0.2 mmol/kg
Hide Arm/Group Description:
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

Overall Number of Participants Analyzed 5 6 6 6 6 6 3 3 2 3
Mean (Standard Deviation)
Unit of Measure: hours
1.65  (0.43) 1.50  (0.22) 1.58  (0.30) 1.73  (0.26) 1.82  (0.35) 2.09  (0.15) 1.90  (0.04) 2.04  (0.06) 1.79  (0.17) 1.94  (0.06)
3.Primary Outcome
Title PK Parameter Cl
Hide Description Cl = total clearance. Blood samples were taken to assess the P03277 concentration.
Time Frame From baseline (30 minutes before injection) to 24 hours post-injection
Hide Outcome Measure Data
Hide Analysis Population Description

In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).

In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).

Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part II (Phase IIA) 0.05 mmol/kg Part II (Phase IIA) 0.075 mmol/kg Part II (Phase IIA) 0.1 mmol/kg Part II (Phase IIA) 0.2 mmol/kg
Hide Arm/Group Description:
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

Overall Number of Participants Analyzed 5 6 6 6 6 6 3 3 2 3
Mean (Standard Deviation)
Unit of Measure: mL/min
91.7  (8.5) 100.1  (9.5) 106.4  (20.7) 96.1  (11.8) 101.3  (10.9) 102.2  (19.0) 105.3  (13.5) 106.5  (15.7) 108.6  (5) 109.9  (18.2)
4.Primary Outcome
Title PK Parameter Vd
Hide Description Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.
Time Frame From baseline (30 minutes before injection) to 24 hours post-injection
Hide Outcome Measure Data
Hide Analysis Population Description

In part I, one patient from the "0.025 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).

In part II, one patient from the "0.1 mmol/kg" group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation).

Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part II (Phase IIA) 0.05 mmol/kg Part II (Phase IIA) 0.075 mmol/kg Part II (Phase IIA) 0.1 mmol/kg Part II (Phase IIA) 0.2 mmol/kg
Hide Arm/Group Description:
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
6 subjects received P03277 in one single administration. P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

In each dose group, all 3 patients received one single administration of P03277.

P03277 was administered intravenously with a flow rate of 2 mL/s.

Overall Number of Participants Analyzed 5 6 6 6 6 6 3 3 2 3
Mean (Standard Deviation)
Unit of Measure: mL
13203  (4122) 12945  (1692) 14312  (2742) 14351  (2645) 15922  (3224) 18487  (3575) 17320  (1942) 18796  (2478) 16823  (804) 18355  (2522)
Time Frame For Part I: adverse events were collected from subjects' enrollment until 7 days after the product (P03277 or placebo) administration. For Part II: adverse events were collected from patients' enrollment until 1 day after P03277 administration.
Adverse Event Reporting Description All adverse events occuring pre- and post-injection are reported below.
 
Arm/Group Title Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg
Hide Arm/Group Description 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.025 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s. 6 subjects received P03277 in one single administration. P03277 was administered intravenously at 0.3 mmol/kg with a flow rate ranging from 0.5 to 2 mL/s.

3 healthy subjects per dose group received placebo in one single administration.

Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.

3 patients received one single administration of P03277. P03277 was administered intravenously at 0.05 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.075 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.1 mmol/kg with a flow rate of 2 mL/s. 3 patients received one single administration of P03277. P03277 was administered intravenously at 0.2 mmol/kg with a flow rate of 2 mL/s.
All-Cause Mortality
Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/18 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/18 (0.00%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      0/3 (0.00%)    
Surgical and medical procedures                       
Abortion induced  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA v16.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part I (Phase I) P03277 0.025 mmol/kg Part I (Phase I) P03277 0.05 mmol/kg Part I (Phase I) P03277 0.075 mmol/kg Part I (Phase I) P03277 0.1 mmol/kg Part I (Phase I) P03277 0.2 mmol/kg Part I (Phase I) P03277 0.3 mmol/kg Part I (Phase I) Placebo Part II (Phase IIA) P03277 0.05 mmol/kg Part II (Phase IIA) P03277 0.075 mmol/kg Part II (Phase IIA) P03277 0.1 mmol/kg Part II (Phase IIA) P03277 0.2 mmol/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      3/6 (50.00%)      2/6 (33.33%)      4/6 (66.67%)      5/6 (83.33%)      3/6 (50.00%)      11/18 (61.11%)      1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      2/3 (66.67%)    
Eye disorders                       
Conjunctivitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders                       
Abdominal pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
General disorders                       
Injection site pain  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 3/18 (16.67%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Catheter site pain  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Injection site oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Catheter site dermatitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Catheter site inflammation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injection site coldness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injection site erythema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injection site haematoma  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injection site haemorrhage  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injection site inflammation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Influenza like illness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0
Infections and infestations                       
Nasopharyngitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications                       
Contusion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Investigations                       
Body temperature increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders                       
Decreased appetite  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders                       
Headache  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  2 2/6 (33.33%)  3 5/18 (27.78%)  5 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Dizziness  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Dizziness postural  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                       
Pregnancy  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Dysphonia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Dyspnoea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Throat irritation  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Sneezing  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders                       
Dermatitis contact  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/18 (5.56%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders                       
Flushing  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/18 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jing Hao, MD
Organization: Guerbet
Phone: +33 (0) 1 45 91 50 00
EMail: jing.hao@guerbet.com
Layout table for additonal information
Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03603106     History of Changes
Other Study ID Numbers: GDX-44-003
2013-004428-12 ( EudraCT Number )
First Submitted: July 16, 2018
First Posted: July 27, 2018
Results First Submitted: November 20, 2018
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019