Recruiting
Phase 1

Nemtabrutinib

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07734610

Conditions

Severe Renal Impairment

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Nemtabrutinib

Study Details

Brief summary:

The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.

Conditions

Severe Renal Impairment

Healthy

Study ID

NCT07734610

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

  • Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m\^2

Participants with Severe Renal impairment (RI):

  • The participant has stable renal function as determined by historical measurements.

Healthy volunteers:

  • Is medically healthy with no clinically significant medical history

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Renal Impairment Participants:

  • History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.

Healthy Matched Control Participants:

  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nemtabrutinib

All participants will receive a single oral dose of nemtabrutinib on Day 1.

Interventions

Nemtabrutinib

Oral administration

Primary outcome measure

  • Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma [ Time Frame: At designated timepoints up to approximately 336 hours postdose ]

Central Contacts and Locations

Central contacts

Locations

Floridian Clinical Research, LLC ( Site 0001)

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Study Coordinator

305-330-9977

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-17.