Infection, Human Immunodeficiency VirusPhase 1NCT02480894
A Open-label, Drug-Drug Interaction With Maraviroc (DDI)
A Phase 1 study testing BMS-663068 and Maraviroc in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. 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 and Maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2015to 21 Sep 2015
- 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 male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion
Who cannot join
- Any condition possibly affecting drug absorption
- Pre-existing liver dysfunction
- Any significant acute or chronic medical illness
- Orthostatic intolerance
- Other protocol specified exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068, Maraviroc
- 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
MaravirocDrug
Maraviroc
| Study group | Role | What they receive |
|---|---|---|
| Sequential Dosing | Experimental | Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18 Receives: Drug: BMS-663068; Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:
- Cmax
Measured: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include:
- AUC(TAU)
Measured: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Maraviroc Pharmacokinetics: Cmax
PK parameters for maraviroc in the absence or presence of BMS-663068 include:
- Cmax
Measured: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Maraviroc Pharmacokinetics: AUC(TAU)
PK parameters for maraviroc in the absence or presence of BMS-663068 include:
- AUC(TAU)
Measured: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Secondary outcomes (11)
Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
PK parameters for BMS-626529 include:
- Tmax
Measured: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
PK parameters for BMS-626529 include:
- C12
Measured: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
PK parameters for BMS-626529 include:
- Ctrough (predose)
Measured: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for maraviroc: Tmax
PK Parameters for maraviroc include:
-Tmax
Measured: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: C12
PK Parameters for maraviroc include:
- C12
Measured: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: Ctrough
PK Parameters for maraviroc include:
- Ctrough
Measured: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Clinical Safety as Measured by Adverse Events
Adverse event monitoring
Measured: Day 1 to Day 26
Clinical Safety as Measured by Vital Signs
Vital sign measurement
Measured: Day 1 to Day 26
Clinical Safety as Measured by Electrocardiograms (ECGs)
12-lead ECGs
Measured: Day 1 to Day 26
Clinical Safety as Measured by Physical Examination
Physical examinations
Measured: Day 1 to Day 26
Clinical Safety as Measured by Clinical Laboratory Evaluations
Clinical chemistry, hematology, urinalysis
Measured: Day 1 to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start7 Jul 2015
- Primary completion21 Sep 2015
- Study completion21 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480894
- Sponsor's protocol ID
- 206278
- Other IDs
- AI438-052
- Status last verified
- Sep 2017
- First submitted
- 16 Jun 2015
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wire MB, Magee M, Ackerman P, Llamoso C, Moore K. Evaluation of the pharmacokinetic drug-drug interaction between the antiretroviral agents fostemsavir and maraviroc: a single-sequence crossover study in healthy participants. HIV Res Clin Pract. 2021 Dec 9;23(1):1-8. Epub 2022 Mar 14.
PubMed 35285786
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02480894
- Acronym / sponsor ID
- 206278
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 21 Sep 2015 (actual)
- Study completion
- 21 Sep 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential Dosing | Experimental | Drug: BMS-663068, Drug: MaravirocTreatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion
Key exclusion criteria (5 listed)
- Any condition possibly affecting drug absorption
- Pre-existing liver dysfunction
- Any significant acute or chronic medical illness
- Orthostatic intolerance
- Other protocol specified exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-663068BMS-663068 | Drug | Sequential Dosing |
| MaravirocMaraviroc | Drug | Sequential Dosing |
Primary outcome
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax
BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU)
Maraviroc Pharmacokinetics: Cmax
Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax
Maraviroc Pharmacokinetics: AUC(TAU)
Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU)
11 secondary outcomes
Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Other PK Parameters for maraviroc: Tmax
Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: C12
Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Other PK Parameters for maraviroc: Ctrough
Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Clinical Safety as Measured by Adverse Events
Time frame: Day 1 to Day 26
Clinical Safety as Measured by Vital Signs
Time frame: Day 1 to Day 26
Clinical Safety as Measured by Electrocardiograms (ECGs)
Time frame: Day 1 to Day 26
Clinical Safety as Measured by Physical Examination
Time frame: Day 1 to Day 26
Clinical Safety as Measured by Clinical Laboratory Evaluations
Time frame: Day 1 to Day 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Derived from this study: PubMed 35285786Wire MB, Magee M, Ackerman P, Llamoso C, Moore K. Evaluation of the pharmacokinetic drug-drug interaction between the antiretroviral agents fostemsavir and maraviroc: a single-sequence crossover study in healthy participants. HIV Res Clin Pract. 2021 Dec 9;23(1):1-8. Epub 2022 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-663068 and Maraviroc in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site 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 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax) (time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18). The study lists 4 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 NCT02480894, 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 25 Sep 2017.