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

ConditionsPsoriasisHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is in good health

Has a BMI between 18 and 36 kg/m², inclusive

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MK-8644

    Drug

    Oral administration

  • Placebo for MK-8644

    Drug

    Oral administration

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: MK-8644Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to approximately 43 days
2

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

Time frame
Up to approximately 28 days

Secondary outcomes

1

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

Blood samples will be collected at designated timepoints to determine the C24 of MK-8644

Time frame
At designated timepoints up to 24 hours post-dose
2

Maximum Plasma Concentration (Cmax) of MK-8644

Blood samples will be collected at designated timepoints to determine the Cmax of MK-8644

Time frame
Predose and at designated timepoints up to 4 days post-dose
3

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

Blood samples will be collected at designated timepoints to determine the Tmax of MK-8644

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

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

Blood samples will be collected at designated timepoints to determine the AUC0-Last of MK-8644

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: