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Pharmacokinetics of Oral CK-1827452 in Patients With Stable Heart Failure

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ClinicalTrials.gov Identifier: NCT00941681
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : December 21, 2010
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Drug: CK-1827452
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Period Title: Overall Study
Started 12 11 12
Completed 12 10 12
Not Completed 0 1 0
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID Total
Hide Arm/Group Description Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days Total of all reporting groups
Overall Number of Baseline Participants 12 11 12 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 12 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  58.3%
8
  72.7%
6
  50.0%
21
  60.0%
>=65 years
5
  41.7%
3
  27.3%
6
  50.0%
14
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 12 participants 35 participants
64.1  (7.74) 61.1  (7.97) 62.4  (11.51) 62.6  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 12 participants 35 participants
Female
4
  33.3%
3
  27.3%
4
  33.3%
11
  31.4%
Male
8
  66.7%
8
  72.7%
8
  66.7%
24
  68.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Georgia Number Analyzed 12 participants 11 participants 12 participants 35 participants
12 11 12 35
1.Primary Outcome
Title C Max (Day 1, Dose 1)
Hide Description Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 11 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
58  (27) 243  (148) 209  (164)
2.Primary Outcome
Title T Max (Day 1, Dose 1)
Hide Description Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 11 8
Mean (Standard Deviation)
Unit of Measure: hr
3.5  (2.9) 3.7  (3.7) 3.5  (3.9)
3.Primary Outcome
Title AUC (Day 1, Dose 1)
Hide Description Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 11 8
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
446  (206) 1003  (387) 1650  (1354)
4.Primary Outcome
Title C Max (Day 10)
Hide Description Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 10 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
205  (111) 420  (158) 704  (494)
5.Primary Outcome
Title T Max (Day 10)
Hide Description Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 10 8
Mean (Standard Deviation)
Unit of Measure: hr
1.8  (0.9) 1.8  (1.1) 2.7  (1.6)
6.Primary Outcome
Title AUC (Day 10)
Hide Description Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description:
Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
Overall Number of Participants Analyzed 12 10 8
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
1886  (1002) 2118  (623) 6457  (5147)
7.Secondary Outcome
Title Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure.
Hide Description [Not Specified]
Time Frame 1 week
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Hide Arm/Group Description Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days. Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days. Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
All-Cause Mortality
Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/11 (9.09%)      0/12 (0.00%)    
General disorders       
Sudden death * 1 [1]  0/12 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA 10.0
[1]
Reported as unrelated to treatment by Investigator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: MR 50 mg BID Cohort 2: IR 37.5 mg TID Cohort 3: MR 100 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)      2/12 (16.67%)    
Cardiac disorders       
Ventricular extrasystoles  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
General disorders       
Influenza like illness  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA 10.0
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.
Sponsor intends to publish the results of the trial in collaboration with the Investigators.
Results Point of Contact
Name/Title: Project Manager
Organization: Cytokinetics, Inc.
Phone: 650-624-2918
Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT00941681     History of Changes
Other Study ID Numbers: CY 1021
First Submitted: July 15, 2009
First Posted: July 17, 2009
Results First Submitted: October 29, 2010
Results First Posted: December 21, 2010
Last Update Posted: February 12, 2013