Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-3281 · 1 trial · 1 indication
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
| Arm | Type | Description |
|---|---|---|
| Pt 1: MK-3281 100 mg BID (Panel A) | EXPERIMENTAL | Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10. |
| Pt 1: MK-3281 200 mg BID (Panel B) | EXPERIMENTAL | Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10. |
| Pt 1: MK-3281 400 mg BID (Panel C) | EXPERIMENTAL | Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10. |
| Pt 1: MK-3281 800 mg BID (Panel D) | EXPERIMENTAL | Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10. |
| Pt 2: MK-3281 800 mg BID (Panel E) | EXPERIMENTAL | Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7. |
| Pt 2: MK-3281 800 mg BID (Panel F) | EXPERIMENTAL | GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7. |
| Pt 2: MK-3281 1200 mg BID (Panel G) | EXPERIMENTAL | GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7. |
| Placebo | PLACEBO_COMPARATOR | Participants receive dose-matched placebo to MK-3281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation). |
| Name | Type | Description |
|---|---|---|
| MK-3281 | DRUG | MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males) |
| Placebo to MK-3281 | DRUG | Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation). |
Inclusion Criteria: * Participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug * Participant has no clinical...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
MK-3281 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy.
MK-3281 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in participants with Hepatitis C.
MK-3281 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy volunteers and Hepatitis C infected participants.
MK-3281 has one completed clinical trial, identified as NCT00635804. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of MK-3281 in healthy and Hepatitis C infected male participants. The trial enrolled 60 participants and was placebo-controlled and double-blind.
No alternative names for MK-3281 have been reported. The drug is identified solely by its investigational code name MK-3281 in clinical trial records and development documentation.