A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

NCT06719557 | Completed Phase 1 FDA Drug

• 3 other identifiers: 1084-008MK-1084-008CA43207
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib

  Blood samples will be collected to determine the AUC0-Inf of calderasib.

  Pre-dose and at designated time points up to 72 hours post dose

Secondary Outcomes (10)

• Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib

  Pre-dose and at designated time points up to 72 hours post dose

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib

  Pre-dose and at designated time points up to 24 hours post dose

• Maximum Plasma Concentration (Cmax) of Calderasib

  Pre-dose and at designated time points up to 72 hours post dose

• Plasma Concentration at 24 Hours (C24) of Calderasib

  Pre-dose and at designated time points up to 24 hours post dose

• Time to Maximum Plasma Concentration (Tmax) of Calderasib

  Pre-dose and at designated time points up to 72 hours post dose

Study Arms (2)

Part 1: Calderasib + Itraconazole

EXPERIMENTAL

Part 1: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of calderasib administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.

Drug: Calderasib; Drug: Itraconazole

Part 2: Calderasib + Phenytoin

EXPERIMENTAL

Part 2: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of calderasib co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2.

Drug: Calderasib; Drug: Phenytoin

Interventions

Itraconazole DRUG

Oral solution

Part 1: Calderasib + Itraconazole

Phenytoin DRUG

Oral capsule (extended)

Part 2: Calderasib + Phenytoin

Calderasib DRUG

Oral Tablet

Also known as: MK-1084

Part 1: Calderasib + Itraconazole; Part 2: Calderasib + Phenytoin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

You may not qualify if:

• History of cancer (malignancy)
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
• Part 1 Only:
• \- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
• Pat 2 Only:
• \- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Itraconazole; Phenytoin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Hydantoins; Imidazolidines; Imidazoles

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: May 20, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)