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CompletedNCT05335447Updated Jun 30, 2022

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667

A Phase 1 interventional study of GLPG3667 capsule and [14C]-GLPG3667 solution for infusion in Healthy, sponsored by Lakefront Biotherapeutics NV. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Lakefront Biotherapeutics NV · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
30 Years to 64 Years
Sex
Male
01

Study summary

This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Lakefront Biotherapeutics NV is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • Has a regular daily defecation pattern (i.e. 1 to 3 times per day).
  • Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal range. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to GLPG3667 ingredients or history of a significant allergic reaction to GLPG3667 ingredients as determined by the investigator
  • Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, COVID-19 vaccines, dietary supplements, nutraceuticals, vitamins and/or herbal supplements), except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
  • Subject 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 millisievert (mSv) in the last 12 months 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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Period 1 - Absolute Bioavailability

    Drug: GLPG3667 capsule · Drug: [14C]-GLPG3667 solution for infusion

  • Experimental
    Period 2 - Mass Balance

    Drug: [14C]-GLPG3667 capsule

Interventions

06

What researchers measure

Primary outcomes

  1. Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)

    Time frame: From Day 1 until at least Day 8 in Period 2

  2. Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)

    Time frame: From Day 1 until at least Day 8 in Period 2

  3. Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)

    Time frame: From Day 1 until at least Day 8 in Period 2

  4. Percentage of TRA in plasma and excreta for metabolites of interest

    Time frame: From Day 1 until at least Day 8 in Period 2

  5. Absolute oral bioavailability (F[percentage]) of GLPG3667

    Time frame: From Day 1 until Day 4 in Period 1

Secondary outcomes

  1. Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.

    Time frame: From Day 1 through study completion, an average of 2 months

07

Study locations

1 site
  • Quotient Sciences Limited
    Nottingham, NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05335447
Responsible party
Sponsor
First posted
Apr 19, 2022
Start date
Apr 19, 2022
Primary completion
Jun 3, 2022
Completion
Jun 3, 2022
Last update
Jun 30, 2022

Study contacts

Galapagos Study Director, MD
study director · Lakefront Biotherapeutics NV

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cadefrecitinib

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