HealthyPhase 1NCT01538420
GLPG0492 Pharmacodynamics
A Phase 1 study testing GLPG0492 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG0492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- smoking
- drug or alcohol abuse
- hypersensitivity to any of the ingredients of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
- Being tested
- GLPG0492, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0492Drug
Oral solution
PlaceboDrug
Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GLPG0492 |
| Placebo | Placebo comparator | Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One week
Secondary outcomes (2)
To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492
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
Measured: Up to 24h hours after last treatment
In female volunteers: effects on hormone household.
In female volunteers the effect of two weeks treatment on hormone levels in the blood will be assessed.
Measured: up to 7 to 10 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florence Namour, MSc, Study director, Galapagos SASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538420
- Sponsor's protocol ID
- GLPG0492-CL-103
- Other IDs
- 2011-004743-41
- Status last verified
- Apr 2012
- First submitted
- 20 Feb 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01538420
- Acronym / sponsor ID
- GLPG0492-CL-103
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG0492 oral solution | Experimental | Drug: GLPG0492Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral solution, once daily for 7 days (part 1) or 14 days (part 2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- smoking
- drug or alcohol abuse
- hypersensitivity to any of the ingredients of the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG0492Oral solution | Drug | GLPG0492 oral solution |
| PlaceboPlacebo oral solution | Drug | Placebo |
Primary outcome
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
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.
2 secondary outcomes
To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492
Time frame: Up to 24h hours after last treatment
In female volunteers: effects on hormone household.
Time frame: up to 7 to 10 days after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Namour, MSc study director
Galapagos SASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG0492 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.