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Recruiting NCT07479745

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

Phase I Interventional Healthy Male Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [14C]GRT6019.
Who it may be relevant to
Registry conditions: Healthy Male Volunteers. Basic parameters: 30 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants

Overview

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

Detailed 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.

Interventions

  • Drug [14C]GRT6019
    Single administration in a single dosing period.

Primary outcome measures

  • Cumulative amount of total radioactivity excreted (CumAe) [Time frame: Day -1 (Admission), Day 1 up to Days 47-48.]
  • Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae) [Time frame: Day -1 (Admission), Day 1 up to Days 47-48.]
  • Metabolite profling and structural identification [Time frame: Day -1 (Admission), Day 1 up to Days 47-48.]

Eligibility criteria

Inclusion criteria

  • Healthy volunteers
  • Aged 30 to 65 years inclusive at the time of signing informed consent

Exclusion criteria

  • Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
  • Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • 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
  • History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United Kingdom · 1 center
  • Quotient Sciences — Nottingham

Identifiers

NCT: NCT07479745 · HP6019-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗