HealthyPhase 1NCT03102567
This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy Subjects
A Phase 1 study testing GLPG1205 50mg q.d. and GLPG1205 250 loading dose and 50mg q.d. maintenance dose in people with Healthy and Elderly, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- GLPG1205 50mg q.d. and GLPG1205 250 loading dose and 50mg q.d. maintenance dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2016to 13 Feb 2017
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, aged over 18 years
- Able and willing to sign the ICF.
- Able and willing to comply with the requirements of the study.
- Body Mass Index (BMI) between 18 and 30 kg/m² inclusive.
- Weight between 60 and 90 kg, inclusive (Cohort A only).
- Considered by the Investigator to be in good health.
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- Discontinuation of all medications with the exception of occasional paracetamol
- Have a creatinine clearance (estimated by Cockroft-Gault equation) > 80 mL/min for subjects aged up to 50 years in cohort C and > 60 mL/min for subjects of 65 years and over in cohorts A, B and D.
- A non-smoker and not using any nicotine-containing products .
- Negative tests for drug screen, alcohol screen, and cotinine screen.
- Male subjects and their female partners of child-bearing potential must agree to use a highly effective method of contraception.
Who cannot join
- Known hypersensitivity to GLPG1205 or excipients of the formulation. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
- Positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Clinically significant illness in the 12 weeks prior to study screening.
- Current or sequelae of gastrointestinal, liver or kidney disease or any other condition that might interfere with absorption, distribution, metabolism or excretion of drugs.
- History of malignancy in the last 5 years.
- Clinically significant abnormalities on ECG of rhythm or conduction
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- Clinically significant abnormalities detected on physical examination or vital signs.
- Clinically significant abnormalities detected on laboratory safety testing
- Significant blood loss, including blood donation of > 450 mL, or receiving a blood transfusion or blood product in the 12 weeks prior to study screening.
- Active drug or alcohol abuse within 2 years prior to study screening.
- Consumption of large quantities of caffeinated coffee or tea (> 6 cups/day), or equivalent. The consumption of alcohol, methyl-xanthine-containing beverages or foods (e.g., coffee, tea cocoa, cola and chocolate), quinine (e.g., tonic water), grapefruit or grapefruit juice, Seville oranges and poppy seeds within 48 h of study medication administration until the end of the dosing period.
- Concurrent or recent participation in an investigational medicinal research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect of Aging of Multiple Oral Doses of GLPG1205 in Healthy Male Subjects
This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects.
The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.
Read the detailed description
In Part 1, a total of 24 healthy male subjects matched for weight will be divided into 3 age groups:
- Cohort A: 8 subjects aged 65 to 74 years, inclusive
- Cohort B: 8 subjects aged ≥ 75 years (1:1 weight matched with subjects of Cohort A [±5 kg])
- Cohort C: 8 subjects aged between 18-50 years, inclusive (1:1 weight matched with subjects of Cohort A [±5 kg])
Each cohort will be randomized 3:1 to active (6 subjects) and placebo (2 subjects) treatment respectively. Weight matched subjects in Cohorts B and C will be assigned to active treatment and placebo accordingly. Cohorts A and C will be dosed with 50 mg q.d. GLPG1205 for 14 days.
In the open-label Part 2, an additional cohort of 8 subjects aged 65-74 years (Cohort D) will be included to characterize the PK profile after a loading dose followed by multiple doses of GLPG1205 q.d. for 13 days. A 250 mg loading dose will be administered on Day 1 followed by 50 mg q.d. from Day 2 to Day 14.
- Being tested
- GLPG1205 50mg q.d., Placebo oral capsule, GLPG1205 250 loading dose and 50mg q.d. maintenance dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1205 50mg q.d.Drug
oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
Placebo oral capsuleDrug
oral gelatin capsule containing placebo to match study arm 1 - q.d. administration
GLPG1205 250 loading dose and 50mg q.d. maintenance doseDrug
Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration
| Study group | Role | What they receive |
|---|---|---|
| GLPG1205 50mg q.d. | Experimental | oral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo Receives: Drug: GLPG1205 50mg q.d. |
| placebo | Placebo comparator | oral hard gelatin capsules containing placebo for q.d. administration Receives: Drug: Placebo oral capsule |
| GLPG1205 250 mg loading and 50mg q.d. maintenance | Experimental | open label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration Receives: Drug: GLPG1205 250 loading dose and 50mg q.d. maintenance dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events
to assess safety and tolerability in the first placebo controlled part of the study
Measured: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations
to assess safety and tolerability in the first placebo controlled part of the study
Measured: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs
to assess safety and tolerability in the first placebo controlled part of the study
Measured: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG
to assess safety and tolerability in the first placebo controlled part of the study
Measured: From screening until the final follow up visit (day 35)
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination
to assess safety and tolerability in the first placebo controlled part of the study
Measured: From screening until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of Cmax of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of tmax of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205
To assess PK of GLPG1205 in the first part of the study with different age groups
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
In the open label (part 2) of the study
Measured: From day 1 pre-dose until the final follow up visit (day 35)
Secondary outcomes (1)
Assessment of creatinine clearance in healthy elderly subjects
To assess renal function in healthy elderly subjects
Measured: From screening until the final follow up visit (day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start18 Oct 2016
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Timis, MBChB MICR, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102567
- Sponsor's protocol ID
- GLPG1205-CL-105
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect of Aging of Multiple Oral Doses of GLPG1205 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03102567
- Acronym / sponsor ID
- GLPG1205-CL-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects.
The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.
Detailed description
In Part 1, a total of 24 healthy male subjects matched for weight will be divided into 3 age groups:
- Cohort A: 8 subjects aged 65 to 74 years, inclusive
- Cohort B: 8 subjects aged ≥ 75 years (1:1 weight matched with subjects of Cohort A [±5 kg])
- Cohort C: 8 subjects aged between 18-50 years, inclusive (1:1 weight matched with subjects of Cohort A [±5 kg])
Each cohort will be randomized 3:1 to active (6 subjects) and placebo (2 subjects) treatment respectively. Weight matched subjects in Cohorts B and C will be assigned to active treatment and placebo accordingly. Cohorts A and C will be dosed with 50 mg q.d. GLPG1205 for 14 days.
In the open-label Part 2, an additional cohort of 8 subjects aged 65-74 years (Cohort D) will be included to characterize the PK profile after a loading dose followed by multiple doses of GLPG1205 q.d. for 13 days. A 250 mg loading dose will be administered on Day 1 followed by 50 mg q.d. from Day 2 to Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG1205 50mg q.d. | Experimental | Drug: GLPG1205 50mg q.d.oral hard gelatin capsules with 50 mg GLPG1205 for q.d. administration - compared to placebo |
| placebo | Placebo comparator | Drug: Placebo oral capsuleoral hard gelatin capsules containing placebo for q.d. administration |
| GLPG1205 250 mg loading and 50mg q.d. maintenance | Experimental | Drug: GLPG1205 250 loading dose and 50mg q.d. maintenance doseopen label - oral hard gelatin capsules with 50 mg GLPG1205 for one time 250 mg loading dose and subsequent 50mg q.d. administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male, aged over 18 years
- Able and willing to sign the ICF.
- Able and willing to comply with the requirements of the study.
- Body Mass Index (BMI) between 18 and 30 kg/m² inclusive.
- Weight between 60 and 90 kg, inclusive (Cohort A only).
Key exclusion criteria (12 listed)
- Known hypersensitivity to GLPG1205 or excipients of the formulation. A history of significant allergic reaction to any drug, such as anaphylaxis requiring hospitalization.
- Positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Clinically significant illness in the 12 weeks prior to study screening.
- Current or sequelae of gastrointestinal, liver or kidney disease or any other condition that might interfere with absorption, distribution, metabolism or excretion of drugs.
- History of malignancy in the last 5 years.
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 50mg q.d.oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo | Drug | GLPG1205 50mg q.d. |
| Placebo oral capsuleoral gelatin capsule containing placebo to match study arm 1 - q.d. administration | Drug | placebo |
| GLPG1205 250 loading dose and 50mg q.d. maintenance doseOpen label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration | Drug | GLPG1205 250 mg loading and 50mg q.d. maintenance |
Primary outcome
Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events
Time frame: From screening until the final follow up visit (day 35)
to assess safety and tolerability in the first placebo controlled part of the study
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal laboratory evaluations
Time frame: From screening until the final follow up visit (day 35)
to assess safety and tolerability in the first placebo controlled part of the study
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal vital signs
Time frame: From screening until the final follow up visit (day 35)
to assess safety and tolerability in the first placebo controlled part of the study
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal ECG
Time frame: From screening until the final follow up visit (day 35)
to assess safety and tolerability in the first placebo controlled part of the study
Difference between the number of healthy male subjects from different age groups and placebo subjects with abnormal physical examination
Time frame: From screening until the final follow up visit (day 35)
to assess safety and tolerability in the first placebo controlled part of the study
Difference between healthy male subjects of different age groups of Cmax of GLPG1205
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
To assess PK of GLPG1205 in the first part of the study with different age groups
Difference between healthy male subjects of different age groups of tmax of GLPG1205
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
To assess PK of GLPG1205 in the first part of the study with different age groups
Difference between healthy male subjects of different age groups of AUC0-t of GLPG1205
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
To assess PK of GLPG1205 in the first part of the study with different age groups
Difference between healthy male subjects of different age groups of apparent terminal half-life (t1/2) of GLPG1205
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
To assess PK of GLPG1205 in the first part of the study with different age groups
Assessment of Cmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
In the open label (part 2) of the study
Assessment of tmax of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
In the open label (part 2) of the study
Assessment of AUC0-t of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
In the open label (part 2) of the study
Assessment of t1/2 of GLPG1205 in subjects having received a loading dose of 250mg and subsequent 50mg q.d. maintenance dose
Time frame: From day 1 pre-dose until the final follow up visit (day 35)
In the open label (part 2) of the study
1 secondary outcome
Assessment of creatinine clearance in healthy elderly subjects
Time frame: From screening until the final follow up visit (day 35)
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 5 Apr 2017.
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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.
Helen Timis, MBChB MICR 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 50mg q.d. and GLPG1205 250 loading dose and 50mg q.d. maintenance dose in people with Healthy and Elderly, 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 11 inclusion and 12 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 5 Apr 2017. 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?
Difference between the number of healthy male subjects from different age groups and placebo subjects with adverse events (time frame: From screening until the final follow up visit (day 35)). The study lists 13 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 5 Apr 2017.