Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8583 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Plasma HIV-1 RNA was measured at baseline and 168 hours after dosing. Change from baseline for MK-8583 at 168 hours post-baseline was estimated from longitudinal data analysis (LDA) model containing fixed effects for time (predose, 168 hours postdose) and a random effect for participant. The change from baseline in plasma HIV-1 RNA in participants administered MK-8583 was compared with historical placebo data.
| Arm | Type | Description |
|---|---|---|
| A: MK-8583 100mg | EXPERIMENTAL | After fasting, a single oral dose of 100 mg MK-8583 in capsule form. |
| B: MK-8583 ≤ 150 mg | EXPERIMENTAL | After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form, with the dose based on the results from earlier treatments |
| C: MK-8583 ≤ 150 mg | EXPERIMENTAL | After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form, with the dose based on the results from earlier treatments |
| Name | Type | Description |
|---|---|---|
| MK-8583 | DRUG | A single oral dose of MK-8583 in capsule form |
Inclusion Criteria: * Male with female partner(s) of child-bearing potential use required methods of birth control. * Female of reproductive potential must demonstrate a nongravid state at the pretrial (screening) visit and agree to use acceptable methods of birth control beginning at the pretrial ...
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MK-8583 is an investigational small molecule being developed for the treatment of HIV-1 infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MK-8583 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK on the New York Stock Exchange.
MK-8583 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study has been completed to evaluate its safety and tolerability in HIV-1 infected participants.
MK-8583 has one completed Phase 1 clinical trial, NCT03552536, titled "MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)." This study enrolled 5 participants in Germany and was not randomized or double-blinded.
No, MK-8583 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for HIV-1 infection. The completed Phase 1 trial was a single-dose study in HIV-1 infected participants.