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AzTrials

Hepatitis CPhase 1NCT02108639

To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

A Phase 1 study testing DCV 3DAA FDC and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
DCV 3DAA FDC and BMS-791325
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
4 sitesUnited States
Study dates
Apr 2014to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects in Group A must be in good health and have normal renal function
  • Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
  • Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods

Who cannot join

  • Subjects in Group A must not have any significant acute or chronic illnesses
  • Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
  • Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
  • Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • New Orleans Center For Clinical Research - Knoxville

    Knoxville, Tennessee, 37920

  • Clinical Pharmacology Of Miami Inc.

    Miami, Florida, 33014

  • Davita Clinical Research

    Minneapolis, Minnesota, 55404

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of DCV, ASV, and BMS-791325 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

Read the detailed description

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses

Fixed dose combination (FDC)

Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)

Conditions
Hepatitis C
Being tested
DCV 3DAA FDC, BMS-791325
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCV 3DAA FDCDrug

    Also called Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325

  • BMS-791325Drug

Study groups in NCT02108639
Study groupRoleWhat they receive
DCV 3DAA FDC + BMS-791325ExperimentalGroup A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
Receives: Drug: DCV 3DAA FDC; Drug: BMS-791325

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712

    Measured: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

  2. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712

    Measured: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

Secondary outcomes (16)

  1. Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  2. Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  3. Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  4. Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  5. Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    BMS-948158 may also be analyzed

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  6. AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    BMS-948158 may also be analyzed

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  7. Protein Binding for DCV, ASV, BMS-791325 and BMS-794712

    Measured: 1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)

  8. Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  9. Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  10. Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  11. Maximum observed concentration (Cmax) for BMS-948158

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  12. Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  13. Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  14. Safety based on abnormalities in vital sign measurements

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  15. Safety based on findings on ECG measurements and physical examinations

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  16. Safety based on Marked abnormalities in clinical laboratory test findings

    Measured: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02108639
Sponsor's protocol ID
AI443-110
Status last verified
Jun 2014
First submitted
7 Apr 2014
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCV 3DAA FDC and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712 (time frame: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02108639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.

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