GLPG0492 Pharmacodynamics

NCT01538420 | Completed Phase 1

• 2 other identifiers: GLPG0492-CL-1032011-004743-41
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

GLPG0492 is a selective androgen receptor modulator: the compound should help protect against (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone). In the first part of the current study it will be tested whether GLPG0492 given orally to healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine. In the second part of the study, the effect of the compound on the "hormone household" in healthy, postmenopausal women will be assessed.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo

  Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability

  Up to 7 to 10 days after last treatment

• In male volunteers: effect on protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine

  During a 5-hour infusion of phenylalanine two muscle biopsies will be taken; this procedure is performed before and after one week of treatment with GLPG0492, to determine the effect of the compound.

  One week

Secondary Outcomes (2)

• To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492

  Up to 24h hours after last treatment

• In female volunteers: effects on hormone household.

  up to 7 to 10 days after treatment.

Study Arms (2)

GLPG0492 oral solution

EXPERIMENTAL

Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day

Drug: GLPG0492

Placebo

PLACEBO COMPARATOR

Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).

Drug: Placebo

Interventions

GLPG0492 DRUG

Oral solution

GLPG0492 oral solution

Placebo DRUG

Placebo oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2)
• Body mass index (BMI) between 18-30 kg/m², inclusive.
• For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L).
• Women must be postmenopausal for at least 2 years with postmenopausal FSH level according to the local lab (+negative pregnancy test at screening \& admission).

You may not qualify if:

• smoking
• drug or alcohol abuse
• hypersensitivity to any of the ingredients of the study drug

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS Stuivenberg

Antwerp, Belgium

Location

MeSH Terms

Interventions

4-(4-(hydroxymethyl)-3-methyl-2,5-dioxo-4-phenylimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile

Study Officials

• Florence Namour, MSc

  Galapagos SASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 24, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 19, 2012

Record last verified: 2012-04

Locations

BE (1)