Clinical trial

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants

NCT05409157

Name

IM018-010

Description

The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.

Trial arms

Trial start

2022-06-17

Estimated PCD

2022-10-15

Trial end

2022-10-15

Status

Completed

Phase

Early phase I

Treatment

BMS-986166

Specified dose on specified days

Arms:

Treatment Group 1: BMS-986166

Bisacodyl

Specified dose on specified days

Arms:

Treatment Group 1: BMS-986166

Other names:

Dulcolax®

Size

Primary endpoint

Total amount of total radioactivity (TRA) recovered in urine (UR)

Up to 90 days

Total amount of TRA recovered in feces (FR)

Up to 90 days

Total amount of TRA recovered in urine and feces combined (RTotal)

Up to 90 days

Percent of TRA recovered in urine (%UR)

Up to 90 days

Percent of TRA recovered in feces (%FR)

Up to 90 days

Percent of TRA recovered in urine and feces combined (%TOTAL)

Up to 90 days

Maximum observed concentration (Cmax)

Up to 89 days

Time of maximum observed concentration (Tmax)

Up to 89 days

Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]

Up to 89 days

Eligibility criteria

Inclusion Criteria: * Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations * Body mass index between 18.0 to 33.0 kg/m2 (inclusive) Exclusion Criteria: * Any significant acute or chronic medical illness * Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week) * History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription Other protocol-defined inclusion/exclusion criteria apply

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

Updated at

2023-03-22

1 organization

2 products

1 indication

Product

Indication

Organization

Product