Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019

Grünenthal

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: [14C]GRT6019

Study type: Interventional

Funder types: Industry

Identifiers

NCT07479745

HP6019-04

Details and patient eligibility

About

The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019

Full description

This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.

Enrollment: 10 estimated patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy volunteers
2. Aged 30 to 65 years inclusive at the time of signing informed consent

Exclusion criteria

1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
3. Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
4. History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder
5. History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

[14C]GRT6019

Experimental group

Description:

Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h.

Treatment:

Drug: [14C]GRT6019