HealthyPhase 1NCT01887106
First-in-Human Single and Multiple Dose of GLPG1205
A Phase 1 study testing GLPG1205 single ascending doses, oral suspension and GLPG1205, multiple ascending doses, oral suspension in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG1205 single ascending doses, oral suspension and GLPG1205, multiple ascending doses, oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Oct 2013
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Who cannot join
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
- Conditions
- Healthy
- Being tested
- GLPG1205 single ascending doses, oral suspension, Placebo single ascending doses, oral suspension, GLPG1205, multiple ascending doses, oral suspension, Placebo, multiple ascending doses, oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1205 single ascending doses, oral suspensionDrug
Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
Placebo single ascending doses, oral suspensionDrug
Single dose, oral suspension matching placebo
GLPG1205, multiple ascending doses, oral suspensionDrug
Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
Placebo, multiple ascending doses, oral suspensionDrug
Multiple doses, daily for 14 days, oral suspension matching placebo
| Study group | Role | What they receive |
|---|---|---|
| GLPG1205 single dose | Experimental | Single oral dose of GLPG1205 suspension - ascending doses Receives: Drug: GLPG1205 single ascending doses, oral suspension |
| Placebo single dose | Placebo comparator | Single oral dose of placebo suspension Receives: Drug: Placebo single ascending doses, oral suspension |
| GLPG1205 multiple doses | Experimental | Multiple oral doses of GLPG1205 suspension - ascending doses Receives: Drug: GLPG1205, multiple ascending doses, oral suspension |
| Placebo multiple doses | Placebo comparator | Multiple oral doses of placebo suspension Receives: Drug: Placebo, multiple ascending doses, oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after single dose
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Measured: Between screening and 7-10 days after the last dose
Safety and tolerability after multiple doses
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Measured: Between screening and 7-10 days after the last dose
Secondary outcomes (5)
The amount of GLPG1205 in plasma and urine over time after a single oral dose
To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects
Measured: Between Day 1 predose and 48 hours post dose
The amount of GLPG1205 in plasma and urine over time after multiple oral doses
To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
Measured: Between Day 1 predose and Day 16 (48 hours after the last dose)
Ratio of 6-b-hydroxycortisol/cortisol in urine
To assess the potential of CYP3A4 induction after repeated dosing with GLPG1205 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
Measured: Twelve hours before dosing on Day 1 and Day 14
Receptor occupancy by GLPG1205 on blood cells after a single dose
To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after a single oral dose in healthy subjects
Measured: Day 1 predose up to 24 hours post dose
Receptor occupancy by GLPG1205 on blood cells after multiple doses
To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after multiple oral doses in healthy subjects
Measured: Day 1 and Day 14, predose up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionOct 2013
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Vanhoutte, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887106
- Sponsor's protocol ID
- GLPG1205-CL-101
- Status last verified
- Oct 2013
- First submitted
- 22 Jun 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01887106
- Acronym / sponsor ID
- GLPG1205-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jun 2013 (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.
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG1205 single dose | Experimental | Drug: GLPG1205 single ascending doses, oral suspensionSingle oral dose of GLPG1205 suspension - ascending doses |
| Placebo single dose | Placebo comparator | Drug: Placebo single ascending doses, oral suspensionSingle oral dose of placebo suspension |
| GLPG1205 multiple doses | Experimental | Drug: GLPG1205, multiple ascending doses, oral suspensionMultiple oral doses of GLPG1205 suspension - ascending doses |
| Placebo multiple doses | Placebo comparator | Drug: Placebo, multiple ascending doses, oral suspensionMultiple oral doses of placebo suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Key exclusion criteria (3 listed)
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
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 |
|---|---|---|
| GLPG1205 single ascending doses, oral suspensionSingle dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg | Drug | GLPG1205 single dose |
| Placebo single ascending doses, oral suspensionSingle dose, oral suspension matching placebo | Drug | Placebo single dose |
| GLPG1205, multiple ascending doses, oral suspensionMultiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg | Drug | GLPG1205 multiple doses |
| Placebo, multiple ascending doses, oral suspensionMultiple doses, daily for 14 days, oral suspension matching placebo | Drug | Placebo multiple doses |
Primary outcome
Safety and tolerability after single dose
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Safety and tolerability after multiple doses
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
5 secondary outcomes
The amount of GLPG1205 in plasma and urine over time after a single oral dose
Time frame: Between Day 1 predose and 48 hours post dose
The amount of GLPG1205 in plasma and urine over time after multiple oral doses
Time frame: Between Day 1 predose and Day 16 (48 hours after the last dose)
Ratio of 6-b-hydroxycortisol/cortisol in urine
Time frame: Twelve hours before dosing on Day 1 and Day 14
Receptor occupancy by GLPG1205 on blood cells after a single dose
Time frame: Day 1 predose up to 24 hours post dose
Receptor occupancy by GLPG1205 on blood cells after multiple doses
Time frame: Day 1 and Day 14, predose up to 24 hours post dose
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 16 Oct 2013.
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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.
Frédéric Vanhoutte, MD study director
Lakefront Biotherapeutics NV
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 GLPG1205 single ascending doses, oral suspension and GLPG1205, multiple ascending doses, oral suspension 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 2 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 16 Oct 2013. 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?
Safety and tolerability after single dose (time frame: Between screening and 7-10 days after the last dose). 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 16 Oct 2013.