A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546715
First received: October 17, 2007
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Daclatasvir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 7 centers in United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 95 participants were enrolled, of which 18 received treatment. Remaining 77 participants were not randomized (participants either no longer met study criteria by the time of randomization or were no longer needed as an adequate number of study participants had already been dosed in each dose panel).

Reporting Groups
  Description
Daclatasvir-1 mg Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Daclatasvir-10 mg Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Daclatasvir-100 mg Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Placebo Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.

Participant Flow:   Overall Study
    Daclatasvir-1 mg     Daclatasvir-10 mg     Daclatasvir-100 mg     Placebo  
STARTED     6     5     5     2  
COMPLETED     6     4     5     2  
NOT COMPLETED     0     1     0     0  
Withdrawal by Subject                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed in the safety population defined as all participants who received any study drug treatment.

Reporting Groups
  Description
Daclatasvir-1 mg Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Daclatasvir-10 mg Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Daclatasvir-100 mg Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Placebo Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
Total Total of all reporting groups

Baseline Measures
    Daclatasvir-1 mg     Daclatasvir-10 mg     Daclatasvir-100 mg     Placebo     Total  
Number of Participants  
[units: participants]
  6     5     5     2     18  
Age  
[units: years]
Median (Full Range)
  43.5  
  (31 to 48)  
  46  
  (23 to 49)  
  44  
  (32 to 45)  
  28  
  (22 to 34)  
  44  
  (22 to 49)  
Gender  
[units: participants]
         
Female     1     3     4     0     8  
Male     5     2     1     2     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died   [ Time Frame: Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs ]

2.  Primary:   Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings   [ Time Frame: Day 1 up to Day 7 or Discharge ]

3.  Primary:   Number of Participants With Marked Abnormalities in Laboratory Findings   [ Time Frame: Day 1 up to Day 7 ]

4.  Secondary:   Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1 ]

5.  Secondary:   Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1 ]

6.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax)   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1 ]

7.  Secondary:   Plasma Half-life (T-half)   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1 ]

8.  Secondary:   Apparent Total Body Clearance (CLT/F)   [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1 ]

9.  Secondary:   Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)   [ Time Frame: Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1 ]

10.  Secondary:   Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline   [ Time Frame: Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1 ]

11.  Secondary:   Change From Baseline in Heart Rate to Day 7 or Discharge   [ Time Frame: Baseline (Day 1), Day 7 or Discharge ]

12.  Secondary:   Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge   [ Time Frame: Baseline (Day 1), Day 7 or Discharge ]

13.  Secondary:   Change From Baseline in Blood Pressure to Day 7 or Discharge   [ Time Frame: Baseline (Day 1), Day 7 or Discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546715     History of Changes
Other Study ID Numbers: AI444-002
Study First Received: October 17, 2007
Results First Received: August 10, 2015
Last Updated: October 20, 2015
Health Authority: United States: Food and Drug Administration