Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14]GLPG3970 oral solution; Drug: GLPG3970 film-coated tablet; Drug: [14C]GLPG3970 solution for infusion

• Registration Number: NCT04907149
• Lead Sponsor: Galapagos NV

Brief Summary

A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Study Start: 2021-06-07
• Status Verified: 2021-07
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
• Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).

This list only contains the key inclusion criteria.

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Exclusion Criteria

• Participant has participated in a [14C]radiolabeled study within the past 12 months.
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.

This list only contains the key exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mass Balance - Period 2	[14]GLPG3970 oral solution	Participants will receive \[14C\]GLPG397 under fasted conditions on Day 1.
Absolute Bioavailability - Period 1	GLPG3970 film-coated tablet	Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.
Absolute Bioavailability - Period 1	[14C]GLPG3970 solution for infusion	Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of \[14C\]GLPG3970 on Day 1.

Primary Outcome Measures

Name	Time	Method
Absolute oral bioavailability (F [%]) of GLPG3970	From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).	From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).	From Day 1 pre-dose until Day 8 in Period 2

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.	From Day 1 through study completion, an average of 1 month

Trial Locations

Locations (1)

Quotient Sciences Ltd; 🇬🇧 Nottingham, United Kingdom