HealthyPhase 1NCT02179502
First-in-Human Single and Multiple Dose of GLPG1690
A Phase 1 study testing GLPG1690 single ascending doses and GLPG1690, 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 GLPG1690 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?
- GLPG1690 single ascending doses and GLPG1690, 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 2014to Dec 2014
- 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-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 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 GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.
Read more
The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.
- Conditions
- Healthy
- Being tested
- GLPG1690 single ascending doses, Placebo single ascending doses, GLPG1690, 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.
GLPG1690 single ascending dosesDrug
Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
Placebo single ascending dosesDrug
Single dose, oral suspension or solid formulation matching placebo
GLPG1690, multiple ascending doses, oral suspensionDrug
Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
Placebo, multiple ascending doses, oral suspensionDrug
Multiple doses, daily for 14 days, oral suspension matching placebo
| Study group | Role | What they receive |
|---|---|---|
| GLPG1690 single dose | Experimental | Single oral dose of GLPG1690 suspension or solid formulation - ascending doses Receives: Drug: GLPG1690 single ascending doses |
| Placebo single dose | Placebo comparator | Single oral dose of placebo suspension or solid formulation Receives: Drug: Placebo single ascending doses |
| GLPG1690 multiple doses | Experimental | Multiple oral doses of GLPG1690 suspension - ascending doses Receives: Drug: GLPG1690, 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.
Number of subjects with adverse events
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination
Measured: Between screening and 7-10 days after the last dose
Secondary outcomes (4)
The amount of GLPG1690 in plasma
To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation
Measured: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG1690 in urine
To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation
Measured: Between Day 1 predose and 24 hours after the (last) dose
Ratio of 6-b-hydroxycortisol/cortisol in urine
To assess the potential of CYP3A4 induction after repeated dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
Measured: Twelve hours before dosing on Day 1 and Day 14
Levels of biomarker in plasma
To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects
Measured: Day 1 predose up to 48 hours post (last) dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT02179502
- Sponsor's protocol ID
- GLPG1690-CL-101
- Other IDs
- 2014-000981-23, 2014
- Status last verified
- Sep 2015
- First submitted
- 28 Jun 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.
PubMed 31012984
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02179502
- Acronym / sponsor ID
- GLPG1690-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 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jul 2014 (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 GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.
The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.
Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 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 |
|---|---|---|
| GLPG1690 single dose | Experimental | Drug: GLPG1690 single ascending dosesSingle oral dose of GLPG1690 suspension or solid formulation - ascending doses |
| Placebo single dose | Placebo comparator | Drug: Placebo single ascending dosesSingle oral dose of placebo suspension or solid formulation |
| GLPG1690 multiple doses | Experimental | Drug: GLPG1690, multiple ascending doses, oral suspensionMultiple oral doses of GLPG1690 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 |
|---|---|---|
| GLPG1690 single ascending dosesSingle dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg | Drug | GLPG1690 single dose |
| Placebo single ascending dosesSingle dose, oral suspension or solid formulation matching placebo | Drug | Placebo single dose |
| GLPG1690, multiple ascending doses, oral suspensionMultiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg | Drug | GLPG1690 multiple doses |
| Placebo, multiple ascending doses, oral suspensionMultiple doses, daily for 14 days, oral suspension matching placebo | Drug | Placebo multiple doses |
Primary outcome
Number of subjects with adverse events
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory parameters
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters
Number of subjects with abnormal vital signs
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs
Number of subjects with abnormal electrocardiogram
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram
Number of subjects with abnormal physical examination
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination
4 secondary outcomes
The amount of GLPG1690 in plasma
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG1690 in urine
Time frame: Between Day 1 predose and 24 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
Levels of biomarker in plasma
Time frame: Day 1 predose up to 48 hours post (last) 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 22 Sep 2015.
- Derived from this study: PubMed 31012984van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.
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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 GLPG1690 single ascending doses and GLPG1690, 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 22 Sep 2015. 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?
Number of subjects with adverse events (time frame: Between screening and 7-10 days after the last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179502, which also lists 1 linked publication.
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 22 Sep 2015.