A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)

NCT07850310 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 8644-001MK-8644
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people. This trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Tolerate means participants will receive MK-8644 in the trial unless they need to stop it due to health problems.

Conditions

Psoriasis; Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  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

  Up to approximately 43 days

• Number of Participants Who Discontinue Study Due to an AE

  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

  Up to approximately 28 days

Secondary Outcomes (5)

• Plasma Concentration at 24 Hours (C24) of MK-8644

  At designated timepoints up to 24 hours post-dose

• Maximum Plasma Concentration (Cmax) of MK-8644

  Predose and at designated timepoints up to 4 days post-dose

• Time to Maximum Plasma Concentration (Tmax) of MK-8644

  Predose and at designated timepoints up to 4 days post-dose

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-8644

  Predose and at designated timepoints up to 4 days post-dose

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-8644

  Predose and at designated timepoints up to 4 days post-dose

Study Arms (2)

MK-8644

EXPERIMENTAL

Participants receive MK-8644 orally under fasted or fed conditions depending on randomization.

Drug: MK-8644

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo for MK-8644 orally under fasted or fed conditions depending on randomization.

Drug: Placebo for MK-8644

Interventions

MK-8644 DRUG

Oral administration

MK-8644

Placebo for MK-8644 DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is in good health
• Has a BMI between 18 and 36 kg/m\^2, inclusive

You may not qualify if:

• Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
• Has a history of cancer.
• Has a history of significant multiple and/or severe allergies.
• Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, tuberculosis, or HIV.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Director

  Merck Sharpe & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 6, 2026
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): December 13, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share