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Infection, Human Immunodeficiency VirusPhase 1NCT02063360

DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

A Phase 1 study testing BMS-663068, Darunavir (DRV) and Ritonavir (RTV) in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.

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

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Infection, Human Immunodeficiency Virus
What is being tested?
BMS-663068, Darunavir (DRV) and Ritonavir (RTV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
1 Feb 2014to 13 May 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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests
  • Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

Who cannot join

  • Any significant acute or chronic medical condition
  • Unable to tolerate oral medications
  • Inability to be venipunctured and/or tolerate venous access
  • Current or recent (within 3 months of dosing) gastrointestinal disease
  • Abnormal liver function test

About this study

Official title: Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

Read the detailed description

Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Being tested
BMS-663068, Darunavir (DRV), Ritonavir (RTV), Etravirine (ETR)
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • BMS-663068Drug

    BMS-663068

  • Darunavir (DRV)Drug

    Also called Prezista

    Darunavir (DRV)

  • Ritonavir (RTV)Drug

    Also called Norvir

    Ritonavir (RTV)

  • Etravirine (ETR)Drug

    Also called Intelence

    Etravirine (ETR)

Study groups in NCT02063360
Study groupRoleWhat they receive
Cohort 1: BMS-663068+DRV/RTVExperimentalExtended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16
Receives: Drug: BMS-663068; Drug: Darunavir (DRV); Drug: Ritonavir (RTV)
Cohort 2: BMS-663068+ETRExperimentalExtended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16
Receives: Drug: BMS-663068; Drug: Etravirine (ETR)
Cohort 3: BMS-663068+DRV/RTV+ETRExperimentalExtended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16
Receives: Drug: BMS-663068; Drug: Darunavir (DRV); Drug: Ritonavir (RTV); Drug: Etravirine (ETR)

What is being measured

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

  1. Maximum observed plasma concentration (Cmax) of BMS-626529

    Measured: 20 timepoints up to day 26

  2. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529

    Measured: 20 timepoints up to day 26

Secondary outcomes (6)

  1. Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR

    Measured: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  2. Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR

    Measured: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  3. Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR

    Measured: Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  4. Cmax for DRV, RTV, and ETR

    Measured: 24 timepoints up to 26 day

  5. AUC(TAU) for DRV, RTV, and ETR

    Measured: 24 timepoints up to 26 day

  6. Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs

    Measured: Up to day 27

Timeline

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

  1. First posted14 Feb 2014 (estimated)
  2. Study start1 Feb 2014
  3. Primary completion1 May 2014
  4. Study completion13 May 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
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063360
Sponsor's protocol ID
206281
Other IDs
AI438-020
Status last verified
Aug 2017
First submitted
13 Feb 2014
Last updated
8 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.

    PubMed 35315687

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-663068, Darunavir (DRV) and Ritonavir (RTV) in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.

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 2 inclusion and 5 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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) of BMS-626529 (time frame: 20 timepoints up to day 26). 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 NCT02063360, which also lists 1 linked publication.

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 8 Aug 2017.

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