Status:
COMPLETED
A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection
Lead Sponsor:
Galapagos NV
Conditions:
Healthy
Eligibility:
MALE
30-64 years
Phase:
PHASE1
Brief Summary
The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). T...
Eligibility Criteria
Inclusion
- Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
- A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
- Having a regular daily defecation pattern (i.e. 1 to 3 times per day).
Exclusion
- Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration.
- Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
- 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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
Key Trial Info
Start Date :
September 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04136327
Start Date
September 13 2019
End Date
October 21 2019
Last Update
November 20 2019
Active Locations (1)
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1
Quotient Sciences Limited
Nottingham, United Kingdom, NG11 6JS