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A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537404
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
R-Pharm

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Narlaprevir
Drug: Ritonavir
Drug: Tenofovir Disoproxil Fumarate
Drug: Raltegravir
Enrollment 36
Recruitment Details Healthy adult volunteers were recruited for all Parts of the study in one clinical site (Bessalar clinic) in Moscow between April and June 2017. 36 subjects were randomized so that 18 subjects participated in each Part of the study (6 subjects in each treatment group of each Part).
Pre-assignment Details Subjects were to be screened within 28 days before dosing in this multi-part study. Subjects were to be admitted to the study center the evening before the first dose for baseline assessments to confirm eligibility.
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description

All patients of Part 1 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 1 of the study.

All patients of Part 2 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 2 of the study.

Period Title: First Intervention (A or B or C)
Started 18 18
Completed 18 18
Not Completed 0 0
Period Title: First Washout Period (8 Days)
Started 18 18
Completed 18 18
Not Completed 0 0
Period Title: Second Intervention (A or B or C)
Started 18 18
Completed 18 18
Not Completed 0 0
Period Title: Second Washout Period (8 Days)
Started 18 18
Completed 18 18
Not Completed 0 0
Period Title: Third Intervention (A or B or C)
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Sequence A/B/C Sequence B/C/A Sequence C/A/B Total
Hide Arm/Group Description

All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:

Treatment period 1 - Treatment A Treatment period 2 - Treatment B Treatment period 3 - Treatment C

All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:

Treatment period 1 - Treatment B Treatment period 2 - Treatment C Treatment period 3 - Treatment A

All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:

Treatment period 1 - Treatment C Treatment period 2 - Treatment A Treatment period 3 - Treatment B

Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 36
Hide Baseline Analysis Population Description
All 36 subjects randomized to study treatment and received at least one dose of study drug (Safety Population).
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Part 1 Number Analyzed 6 participants 6 participants 6 participants 18 participants
24.3  (1.75) 38.3  (8.26) 29.7  (1.86) 30.8  (7.57)
Part 2 Number Analyzed 6 participants 6 participants 6 participants 18 participants
24.3  (4.03) 38.7  (4.59) 29.5  (3.33) 30.8  (7.17)
[1]
Measure Analysis Population Description: Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Part 1 Number Analyzed 6 participants 6 participants 6 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
18
 100.0%
Part 2 Number Analyzed 6 participants 6 participants 6 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
18
 100.0%
[1]
Measure Analysis Population Description: Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Part 1 Number Analyzed 6 participants 6 participants 6 participants 18 participants
White
6
 100.0%
6
 100.0%
5
  83.3%
17
  94.4%
Asian
0
   0.0%
0
   0.0%
1
  16.7%
1
   5.6%
Black
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Part 2 Number Analyzed 6 participants 6 participants 6 participants 18 participants
White
6
 100.0%
5
  83.3%
6
 100.0%
17
  94.4%
Asian
0
   0.0%
1
  16.7%
0
   0.0%
1
   5.6%
Black
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).
Body Mass Index (BMI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Part 1 Number Analyzed 6 participants 6 participants 6 participants 18 participants
23.14  (1.287) 24.73  (3.022) 24.20  (3.134) 24.02  (2.554)
Part 2 Number Analyzed 6 participants 6 participants 6 participants 18 participants
24.26  (4.132) 25.40  (2.732) 25.63  (3.408) 25.10  (3.319)
[1]
Measure Description: Calculated as weight(kg)/height(m^2)
[2]
Measure Analysis Population Description: Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).
1.Primary Outcome
Title Cmax of Narlaprevir
Hide Description Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment A (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:

Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Overall Number of Participants Analyzed 18 18 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng/ml
2130.2742
(1817.4088 to 2731.8348)
2172.233
(1895.673 to 2726.557)
2946.131
(2617.485 to 3799.642)
2880.612
(2412.858 to 4121.871)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A (Part 1), Treatment C (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.020
Confidence Interval (2-Sided) 90%
-0.103 to 0.142
Estimation Comments Cmax parameters were logarithmically transformed
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment A (Part 2), Treatment C (Part 2)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value -0.022
Confidence Interval (2-Sided) 90%
-0.220 to 0.175
Estimation Comments Cmax parameters were logarithmically transformed
2.Primary Outcome
Title AUCtau of Narlaprevir
Hide Description Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment A (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:

Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Overall Number of Participants Analyzed 18 18 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng*h/ml
20504.31
(18265.63 to 24328.95)
21366.2
(18664.1 to 26481.9)
26199.19
(23136.15 to 33132.53)
24458.48
(20738.76 to 33597.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A (Part 1), Treatment C (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.041
Confidence Interval (2-Sided) 90%
-0.075 to 0.157
Estimation Comments AUCtau parameters were logarithmically transformed.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment A (Part 2), Treatment C (Part 2)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value -0.069
Confidence Interval (2-Sided) 90%
-0.201 to 0.064
Estimation Comments AUCtau parameters were logarithmically transformed
3.Primary Outcome
Title Cmax of Tenofovir
Hide Description Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment B (Part 1) Treatment C (Part 1)
Hide Arm/Group Description:

Subjects recieved as Treatment B for 5 days (in respective treatment period):

Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Overall Number of Participants Analyzed 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng/ml
263.037
(233.126 to 313.318)
344.796
(302.457 to 415.092)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment B (Part 1), Treatment C (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.271
Confidence Interval (2-Sided) 90%
0.159 to 0.383
Estimation Comments Cmax parameters were logarithmically transformed
4.Primary Outcome
Title AUCtau of Tenofovir
Hide Description Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment B (Part 1) Treatment C (Part 1)
Hide Arm/Group Description:

Subjects recieved as Treatment B for 5 days (in respective treatment period):

Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).

Overall Number of Participants Analyzed 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng*h/ml
2599.95
(2325.72 to 3043.02)
2799.72
(2536.67 to 3205.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment B (Part 1), Treatment C (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.074
Confidence Interval (2-Sided) 90%
0.016 to 0.132
Estimation Comments AUCtau parameters were logarithmically transformed
5.Primary Outcome
Title Cmax of Raltegravir
Hide Description Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment B (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:

Subjects recieved as Treatment B for 5 days (in respective treatment period):

Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Overall Number of Participants Analyzed 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng/ml
830.204
(520.042 to 2758.109)
715.726
(136.163 to 2396.130)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment B (Part 2), Treatment C (Part 2)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value -0.148
Confidence Interval (2-Sided) 90%
-0.450 to 0.153
Estimation Comments Cmax parameters were logarithmically transformed
6.Primary Outcome
Title AUCtau of Raltegravir
Hide Description Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study
Time Frame Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug.
Arm/Group Title Treatment B (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:

Subjects recieved as Treatment B for 5 days (in respective treatment period):

Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Subjects recieved as Treatment C for 5 days (in respective treatment period):

Narlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).

Overall Number of Participants Analyzed 18 18
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng*h/ml
2912.45
(1983.01 to 8451.44)
2653.65
(1033.88 to 6964.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment B (Part 2), Treatment C (Part 2)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value -0.093
Confidence Interval (2-Sided) 90%
-0.354 to 0.168
Estimation Comments AUCtau parameters were logarithmically transformed
7.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description [Not Specified]
Time Frame Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug
Arm/Group Title Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:
Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Overall Number of Participants Analyzed 18 18 18 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
4
  22.2%
0
   0.0%
0
   0.0%
1
   5.6%
8.Secondary Outcome
Title Number of Patients With Changes in Vital Signs
Hide Description There were no subjects with abnormal changes in vital signs
Time Frame Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug
Arm/Group Title Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
Hide Arm/Group Description:
Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Overall Number of Participants Analyzed 18 18 18 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Patients With Abnormal Laboratory Values
Hide Description [Not Specified]
Time Frame Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug separately for each Patr of the study
Arm/Group Title Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1)
Hide Arm/Group Description:
Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days
Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Overall Number of Participants Analyzed 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Part 1
0
   0.0%
0
   0.0%
2
  11.1%
Part 2
0
   0.0%
0
   0.0%
1
   5.6%
10.Secondary Outcome
Title Number of Patients With Abnormal ECG Changes
Hide Description There were no subjects with abnormal ECG changes during the study
Time Frame Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to study treatment and received at least one dose of study drug
Arm/Group Title Treatment A (Part 1/Part 2) Treatment B (Part 1/Part 2) Treatment C (Part 1/Part 2)
Hide Arm/Group Description:
Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days

Part 1: Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Part 2: Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Part 1: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Part 2: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Overall Number of Participants Analyzed 18 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Part 1
0
   0.0%
0
   0.0%
0
   0.0%
Part 2
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
Hide Arm/Group Description Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily

coadministered with

Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily

and

Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days

All-Cause Mortality
Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
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   0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A (Part 1) Treatment B (Part 1) Treatment C (Part 1) Treatment A (Part 2) Treatment B (Part 2) Treatment C (Part 2)
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   1/18 (5.56%)      0/18 (0.00%)      4/18 (22.22%)      0/18 (0.00%)      0/18 (0.00%)      1/18 (5.56%)    
Gastrointestinal disorders             
Diarrhoea  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Investigations             
Alanine Aminotransferase Increased  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Blood Lactate Dehydrogenase Decreased  1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Gamma-Glutamyltransferase Increased  1  0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders             
Headache  1  1/18 (5.56%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
1
Term from vocabulary, MedRA 19.0
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.
Any study related information could be made public availiable only after Sponsors written permission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emiliya Krasavina, Medical Adviser
Organization: R-Pharm
Phone: 0074959567937
EMail: krasavina@rpharm.ru
Layout table for additonal information
Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT03537404     History of Changes
Other Study ID Numbers: CJ05013019
First Submitted: May 15, 2018
First Posted: May 25, 2018
Results First Submitted: August 31, 2018
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019