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| ID | Type | Description | Link |
|---|---|---|---|
| AI438-052 | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-663068 | Drug | BMS-663068 |
| |
| Maraviroc |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | 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) | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax) | PK parameters for BMS-626529 include: - Tmax | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35285786 | Derived | 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. |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C576364 | fostemsavir |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Maraviroc |
|
PK parameters for BMS-626529 include: - C12 |
| 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) | 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 | 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:
| 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 | 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 | Day 1 to Day 26 |
| Clinical Safety as Measured by Vital Signs | Vital sign measurement | Day 1 to Day 26 |
| Clinical Safety as Measured by Electrocardiograms (ECGs) | 12-lead ECGs | Day 1 to Day 26 |
| Clinical Safety as Measured by Physical Examination | Physical examinations | Day 1 to Day 26 |
| Clinical Safety as Measured by Clinical Laboratory Evaluations | Clinical chemistry, hematology, urinalysis | Day 1 to Day 26 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |