Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970

Sponsor

Galapagos NV (Industry)

Overall Status

Completed

CT.gov ID

NCT04907149

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: GLPG3970 film-coated tablet Drug: [14C]GLPG3970 solution for infusion Drug: [14]GLPG3970 oral solution	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration

Actual Study Start Date :

Jun 7, 2021

Actual Primary Completion Date :

Jul 12, 2021

Actual Study Completion Date :

Jul 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Absolute Bioavailability - Period 1 Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1.	Drug: GLPG3970 film-coated tablet Participants will receive a single oral dose of GLPG3970. Drug: [14C]GLPG3970 solution for infusion Participants will receive an i.v. microtracer microdose.
Experimental: Mass Balance - Period 2 Participants will receive [14C]GLPG397 under fasted conditions on Day 1.	Drug: [14]GLPG3970 oral solution Participants will receive a single oral dose [14C]GLPG3970.

Arm

Intervention/Treatment

Experimental: Absolute Bioavailability - Period 1

Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1.

Drug: GLPG3970 film-coated tablet

Participants will receive a single oral dose of GLPG3970.

Drug: [14C]GLPG3970 solution for infusion

Participants will receive an i.v. microtracer microdose.

Experimental: Mass Balance - Period 2

Participants will receive [14C]GLPG397 under fasted conditions on Day 1.

Drug: [14]GLPG3970 oral solution

Participants will receive a single oral dose [14C]GLPG3970.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Ltd	Nottingham		United Kingdom	NG11 6JS

Sponsors and Collaborators

Galapagos NV

Investigators

Study Director: Ekaterina Tankisheva, Galapagos NV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galapagos NV

ClinicalTrials.gov Identifier:

NCT04907149

Other Study ID Numbers:

GLPG3970-CL-107
2021-000711-23

First Posted:

May 28, 2021

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pharmaceutical Solutions

Study Results

No Results Posted as of Jul 23, 2021