A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)

Conditions

• Hepatic Impairment (HI)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Nemtabrutinib — DRUG
  25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.

Study Details

The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.

Key Dates

Start date

Jul 24, 2024

Status verified

Jan 2026

Primary completion

Sep 14, 2026

Completion

Sep 14, 2026

Study Design

Enrollment

32 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Panel A
  Participants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1.
• Experimental: Panel B
  Healthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1.

Primary Outcome Measure

Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (3)

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