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Completed

NCT Number: NCT01538420

GLPG0492 Pharmacodynamics

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

GLPG0492

Drug

Oral solution

Placebo

Drug

Placebo oral solution

Primary outcomes

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

    Time frame: Up to 7 to 10 days after last treatment

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

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

    Time frame: One week

    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.

Secondary outcomes

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

    Time frame: Up to 24h hours after last treatment

    The plasma levels of GLPG0492 will be determined as a measure of pharmacokinetics, and the plasma and urine samples will be used for metabolism investigation

  2. In female volunteers: effects on hormone household.

    Time frame: up to 7 to 10 days after treatment.

    In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Assessment of the Muscle Protein Fractional Synthesis Rate Induced by Repeated Administrations of GLPG0492 to Healthy Male Subjects and Assessment of the Safety, Tolerability and Pharmacokinetics of Repeated Administrations of GLPG0492 to Healthy Postmenopausal Women.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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