Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]MK-8527, Alimatravir
MK-8527 · 10 trials · 7 indications
The number of participants with adjudicated HIV-1 infection will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be presented.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.
Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.
Breast milk samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Breast milk samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose.
Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf).
Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz).
The mean change from baseline in HIV-1 RNA counts at 168 hours after a single doses of MK-8527 is reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood samples were taken to determine HIV-1 RNA levels at Predose (baseline) and 168 hours postdose. Data were fitted with a longitudinal data analysis (LDA) model containing fixed effects for treatment, time and treatment by time interaction, and a random effect for participant.The change from baseline in plasma HIV-1 RNA in participants administered MK-8527 was calculated and results were compared with historical placebo data.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it is considered related to the medicinal product. The percentage of participants that reported at least 1 AE will be summarized.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it is considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE will be summarized.
| Arm | Type | Description |
|---|---|---|
| MK-8527 + Placebo to FTC/TDF | EXPERIMENTAL | Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| FTC/TDF + Placebo to MK-8527 | ACTIVE_COMPARATOR | Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| MK-8527 | EXPERIMENTAL | Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| FTC/TDF | ACTIVE_COMPARATOR | Participants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days. |
| Alimatravir | EXPERIMENTAL | Alimatravir 11 mg will be taken once monthly (qm) |
| MK-8527 Low Dose QM | EXPERIMENTAL | Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| MK-8527 Medium Dose QM | EXPERIMENTAL | Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| MK-8527 High Dose QM | EXPERIMENTAL | Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| Placebo to MK-8527 | PLACEBO_COMPARATOR | Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| MK-8527 + Rifampin | EXPERIMENTAL | Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment receive a single dose of MK-8527 on Day 1. |
| Healthy | EXPERIMENTAL | Healthy participants receive a single dose of MK-8527 on Day 1. |
| Arm 1: All Participants | EXPERIMENTAL | Participants receive single doses of LNG/EE alone and in combination with a single dose of MK-8527. |
| Panel A: MK-8527 1.0 mg | EXPERIMENTAL | Participants receive a single oral dose of MK-8527 1.0 mg. |
| Panel B: MK-8527 0.5 mg | EXPERIMENTAL | Participants receive a single oral dose of MK-8527 0.5 mg. |
| Panel C: MK-8527 0.25 mg | EXPERIMENTAL | Participants receive a single oral dose of MK-8527 0.25 mg. |
| Panel A: 10 mg MK-8527 | EXPERIMENTAL | Single oral dose of 10 mg MK-8527 capsule after an 8-hour fast |
| Panel B: 3 mg MK-8527 | EXPERIMENTAL | Single oral dose of 3 mg MK-8527 capsule after an 8-hour fast |
| Panel C: 1 mg MK-8527 | EXPERIMENTAL | Single oral dose of 1 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels. |
| Panel D: ≤50 mg MK-8527 | EXPERIMENTAL | Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels. |
| Panel E: ≤50 mg MK-8527 | EXPERIMENTAL | Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels. |
| Name | Type | Description |
|---|---|---|
| MK-8527 | DRUG | Oral tablet |
| Emtricitabine/tenofovir disoproxil (FTC/TDF) | DRUG | Oral tablet |
| Placebo matched to MK-8527 | DRUG | Placebo oral tablet matched to MK-8527 |
| Placebo matched to FTC/TDF | DRUG | Placebo oral tablet matched to FTC/TDF |
| FTC/TDF | DRUG | Oral tablet |
| Placebo to MK-8527 | DRUG | Placebo tablet matched to MK-8527 |
| Placebo to FTC/TDF | DRUG | Placebo tablet matched to FTC/TDF |
| Alimatravir | DRUG | 11 mg tablets taken orally once monthly (qm) for a total of 3 doses |
| Rifampin | DRUG | Administered orally |
| LNG/EE | DRUG | LNG/EE combination tablet taken by mouth. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results * Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) withi...
MK-8527 is an investigational small molecule being developed for the prevention of human immunodeficiency virus type 1 (HIV-1), including HIV pre-exposure prophylaxis. It is also being studied in people with renal impairment and in a drug interaction study involving latent tuberculosis treatment. It is not approved for any use.
MK-8527 targets HIV-1. As a small molecule directed at the virus, it is being developed to prevent HIV-1 infection, with the clinical program focused on pre-exposure prophylaxis in adults and adolescents at risk of acquiring HIV.
MK-8527 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program, which includes Phase 1, Phase 2 and Phase 3 studies of the compound.
MK-8527 is in Phase 2 development overall, and the program includes two large Phase 3 prevention studies that are recruiting or active. It is investigational and has not been approved by the FDA or any other regulatory authority for any indication.
The MK-8527 program includes six trials. Phase 3 prevention studies include NCT07071623 in Kenya, South Africa and Uganda, and NCT07044297 across the United States, Latin America, Africa, Asia and Europe. Phase 1 studies include NCT06783192, a completed contraceptive drug interaction study, and NCT07600775 with rifampin in latent tuberculosis infection.
Yes. [14C]MK-8527 is an alternative name for MK-8527. The bracketed carbon-14 label refers to a radiolabeled version of the same molecule used in clinical pharmacology work, so searches for either name refer to the same Merck compound.