A Phase I, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety, tolerability, pharmacokinetics, including the effect of food, and pharmacodynamics of single and multiple ascending oral doses of GLPG3312, in adult, healthy subjects.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Male or female between 18 to 55 years of age (extremes included), on the date
of signing the ICF. Females should be of non-childbearing potential as defined
in the protocol.
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- Subject must be able and willing to comply with restrictions on prior
medication.
- Male subjects with female partners of childbearing potential must be willing
to comply with contraceptive methods.

Exclusion Criteria

- Positive serology for HBsAg, or HCV, or history of hepatitis from any cause
with the exception of hepatitis A that was resolved at least 3 months prior to
first dosing of the IMP.
- History of, or a current immunosuppressive condition (e.g. HIV infection).
- Having any illness judged by the investigator as clinically significant, in
the 3 months prior to first dosing of the IMP.
- Any history, or current sign or symptom of a cardiovascular, renal, or
metabolic bone disease or disease of bone remodeling, or any history of
endocrine disease, including an abnormal laboratory result for prespecified
clinical laboratory safety parameters related to these conditions.
- History of malignancy within the past 5 years prior to screening with the
exception of excised and curatively treated nonmetastatic cell carcinoma of the
skin or carcinoma in situ of cervix which is considered cured with minimal risk
of recurrence.
- Significant blood loss (including blood donation >450 mL), or transfusion of
any blood product within 12 weeks prior to screening.
- Treatment with any medication (including over-the-counter and/or prescription
medication, dietary supplements, nutraceuticals, vitamins and/or herbal
supplements) except occasional paracetamol (maximum dose of 2 g/day and a
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 of the IMP.
- Active drug abuse or alcohol abuse (alcohol abuse defined as regular weekly
intake of more than 14 units) within 2 years prior to first IMP administration.
- Active smoker and/or has used nicotine or nicotine-containing products within
the past 6 months before the first IMP administration.
- Regular consumption of a large quantity of caffeinated coffee, tea (> 6 cups
per day) or equivalent.
- Concurrent participation or participation in a drug, drug/device or biologic
investigational research study within 12 weeks or 5 half-lives of the IMP,
whichever is longer, prior to first dosing of the IMP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency and severity of treatment-emergent adverse events (TEAEs),<br /><br>treatment-emergent SAEs, and TEAEs leading to treatment discontinuations, in<br /><br>adult, healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Plasma, urine, and stool (Part 4 only) PK parameters of GLPG3312 in adult,<br /><br>healthy subjects: maximum observed plasma concentration (Cmax), area under the<br /><br>plasma concentration-time curve (AUC), Aefeces, AEurine, t1/2.<br /><br><br /><br>Ratio in extent and exposure following dosing of GLPG3312 as a MR formulation,<br /><br>under fed conditions (high-fat high-calorie) versus fasted conditions, in<br /><br>adult, healthy subjects.</p><br>