Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8504 · 1 trial · 1 indication
Plasma samples were collected from participants after a single dose of MK-8504 to assess viral load. The log10 plasma HIV-RNA (copies/mL) measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. Change from baseline to 168 hours post-dose was determined for each treatment group. Results are expressed as change in HIV RNA log10 (copies/mL).
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants experiencing at least one AE was reported for each arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants that discontinued study treatment due to an AE was reported for each arm.
| Arm | Type | Description |
|---|---|---|
| MK-8504 100 mg (Panel A) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 100 mg. |
| MK-8504 240 mg (Panel B) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 240 mg. |
| MK-8504 ≤240 mg (Panel C) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 ≤240 mg. |
| MK-8504 ≤240 mg (Panel D) | EXPERIMENTAL | Participants receive a single oral dose of MK-8504 ≤240 mg. |
| Name | Type | Description |
|---|---|---|
| MK-8504 | DRUG | After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form. |
Inclusion Criteria: * Male or non-pregnant and non-breast feeding female * Have a Body Mass Index (BMI) ≤35 kg/m\^2 * Other than HIV infection, have stable baseline health based on medical history, physical examination, vital sign measurements, and laboratory safety test * Is documented HIV-1 posit...
Top 20 of 28 competitors
MK-8504 is an investigational small molecule being studied for the treatment of HIV-1 infection. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. The drug is intended for use in anti-retroviral-naive, HIV-1 infected participants.
The molecular target of MK-8504 has not been disclosed. It is a small molecule being evaluated for its antiviral activity against HIV-1 infection. The drug is in Phase 1 clinical development, and its specific mechanism of action has not been publicly detailed.
MK-8504 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of HIV-1 infection.
MK-8504 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial of MK-8504 has been completed, and the drug remains under investigation for HIV-1 infection.
MK-8504 has been studied in one completed Phase 1 clinical trial, NCT03188523, titled 'Activity of MK-8504 in Anti-retroviral-naive, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)'. The trial enrolled 12 participants with HIV-1 infection in Germany and the United Kingdom.
No alternative names for MK-8504 have been disclosed. The drug is identified solely by its development code MK-8504 and is being studied by Merck & Company, Inc. for the treatment of HIV-1 infection.