A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)

NCT06586606 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1708-003MK-1708-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708

  Blood samples will be collected to determine the AUC0-inf of MK-1708.

  Predose and at designated timepoints up to approximately 2 weeks postdose

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

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  Up to approximately 11 weeks

• Number of Participants Who Discontinue Study Due to an AE

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.

  Up to approximately 11 weeks

Secondary Outcomes (7)

• Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708

  Predose and at designated timepoints up to approximately 2 weeks postdose

• Maximum Plasma Concentration (Cmax) of MK-1708

  Predose and at designated timepoints up to approximately 2 weeks postdose

• Time to Maximum Plasma Concentration (Tmax) of MK-1708

  Predose and at designated timepoints up to approximately 2 weeks postdose

• Plasma Concentration at 24 Hours (C24) of MK-1708

  Predose and at designated timepoints up to 24 hours postdose

• Apparent Clearance (CL/F) of MK-1708

  Predose and at designated timepoints up to approximately 2 weeks postdose

Study Arms (2)

Period 1: MK-1708

EXPERIMENTAL

Participants will receive a single oral dose of MK-1708 on Day 1.

Drug: MK-1708

Period 2: MK-1708 and Itraconazole

EXPERIMENTAL

A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.

Drug: MK-1708; Drug: Itraconazole

Interventions

MK-1708 DRUG

Oral administration

Period 1: MK-1708; Period 2: MK-1708 and Itraconazole

Itraconazole DRUG

Oral administration

Period 2: MK-1708 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\^2, inclusive

You may not qualify if:

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC ( Site 0001)

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 3, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)