HealthyPhase 1NCT02162355
Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects
A Phase 1 study testing GLPG0634 50 mg, GLPG0634 100 mg and GLPG0634 200 mg in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
Trial summary
The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG0634 50 mg, GLPG0634 100 mg and GLPG0634 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Sep 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
- Subjects must have a body mass index between 18-28 kg/m² (included)
- Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
Who cannot join
- A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
- Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
- A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
- Subject expresses current desire to have (more) children
- Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects
The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.
Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.
- Conditions
- Healthy
- Being tested
- GLPG0634 50 mg, GLPG0634 100 mg, GLPG0634 200 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0634 50 mgDrug
Also called 50 mg GLPG0634 as tablets
2 tablets of 25 mg GLPG0634 once daily for 10 days
GLPG0634 100 mgDrug
Also called 100 mg GLPG0634 as tablets
1 tablet of 100 mg GLPG0634 once daily for 10 days
GLPG0634 200 mgDrug
Also called 200 mg GLPG0634 as tablets
2 tablets of 100 mg GLPG0634 once daily for 10 days
PlaceboDrug
Also called Placebo as matching tablets
1 or 2 matching placebo tablets once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| GLPG0634 in Japanese subjects | Experimental | Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days Receives: Drug: GLPG0634 50 mg; Drug: GLPG0634 100 mg; Drug: GLPG0634 200 mg |
| Placebo in Japanese healthy subjects | Placebo comparator | Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days Receives: Drug: Placebo |
| GLPG0634 in Caucasian subjects | Experimental | In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days Receives: Drug: GLPG0634 200 mg |
| Placebo in Caucasian healthy subjects | Placebo comparator | In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with adverse events
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs)
Measured: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters
Measured: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs
Measured: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram
Measured: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination
Measured: From screening up to 10 days after last dose (Day 20)
The amount of GLPG0634 and metabolite in plasma and urine
To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested
Safety Issue?:
No
Measured: Between Day 1 before dosing and Day 13 (72 hours after last dose)
Secondary outcomes (1)
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood
To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested
Measured: Between Day 1 before dosing and Day 11 (24 hours after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pille Harrison, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162355
- Sponsor's protocol ID
- GLPG0634-CL-110
- Other IDs
- 2013-004408-21
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects
- ClinicalTrials.gov ID
- NCT02162355
- Acronym / sponsor ID
- GLPG0634-CL-110
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jun 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 multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.
Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG0634 in Japanese subjects | Experimental | Drug: GLPG0634 50 mg, Drug: GLPG0634 100 mg, Drug: GLPG0634 200 mgPer panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days |
| Placebo in Japanese healthy subjects | Placebo comparator | Drug: PlaceboPer panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days |
| GLPG0634 in Caucasian subjects | Experimental | Drug: GLPG0634 200 mgIn the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days |
| Placebo in Caucasian healthy subjects | Placebo comparator | Drug: PlaceboIn the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
- Subjects must have a body mass index between 18-28 kg/m² (included)
- Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
Key exclusion criteria (5 listed)
- A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
- Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
- A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
- Subject expresses current desire to have (more) children
- Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding
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 |
|---|---|---|
| GLPG0634 50 mgAlso: 50 mg GLPG0634 as tablets2 tablets of 25 mg GLPG0634 once daily for 10 days | Drug | GLPG0634 in Japanese subjects |
| GLPG0634 100 mgAlso: 100 mg GLPG0634 as tablets1 tablet of 100 mg GLPG0634 once daily for 10 days | Drug | GLPG0634 in Japanese subjects |
| GLPG0634 200 mgAlso: 200 mg GLPG0634 as tablets2 tablets of 100 mg GLPG0634 once daily for 10 days | Drug | GLPG0634 in Caucasian subjects, GLPG0634 in Japanese subjects |
| PlaceboAlso: Placebo as matching tablets1 or 2 matching placebo tablets once daily for 10 days | Drug | Placebo in Caucasian healthy subjects, Placebo in Japanese healthy subjects |
Primary outcome
The number of subjects with adverse events
Time frame: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs)
The number of subjects with abnormal laboratory parameters
Time frame: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters
The number of subjects with abnormal vital signs
Time frame: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs
The number of subjects with abnormal electrocardiogram
Time frame: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram
The number of subjects with abnormal physical examination
Time frame: From screening up to 10 days after last dose (Day 20)
To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination
The amount of GLPG0634 and metabolite in plasma and urine
Time frame: Between Day 1 before dosing and Day 13 (72 hours after last dose)
To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No
1 secondary outcome
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood
Time frame: Between Day 1 before dosing and Day 11 (24 hours after 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 16 Sep 2014.
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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.
Pille Harrison, 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 GLPG0634 50 mg, GLPG0634 100 mg and GLPG0634 200 mg in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
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 3 inclusion and 5 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 Sep 2014. 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 United Kingdom. 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?
The number of subjects with adverse events (time frame: From screening up to 10 days after last dose (Day 20)). The study lists 6 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 Sep 2014.