Renal ImpairmentPhase 1NCT02084199
Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
A Phase 1 study testing GLPG0634 in people with Renal Impairment, run by Lakefront Biotherapeutics NV at 1 site in Germany.
Trial summary
This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- GLPG0634
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Jul 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female white subjects between 18-79 years of age (inclusive)
- Subjects must have a BMI between 18-34 kg/m², inclusive
- Part 1, Group 1: subject with severe renal impairment or ESRD, not on dialysis : eGFR between 15-29 mL/min/1.73 m2 or <15 mL/min/1.73m²
- Part 1, Group 2: subject with normal renal function: eGFR ≥90 mL/min/1.73m²
- Part 2, Group 3: subject with mild renal impairment: eGFR between 60-89 mL/min/1.73 m²
- Part 2, Group 4:subject with moderate renal impairment: eGFR between 30-59 mL/min/1.73 m²
- Part 2, Group 5: subject with normal renal function: eGFR ≥90 mL/min/1.73 m²
- Subjects must be judged to be in good health (subjects with normal renal function)/in a stable condition and acceptable for study participation (subjects with renal impairment) based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory profile
Who cannot join
- A subject with a known hypersensitivity to ingredients of the study medication or a significant allergic reaction to any drug
- Subject has previously participated in a GLPG0634 study or has previously received GLPG0634
- Concurrent participation or participation within 8 weeks 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
- A subject who has a current child wish
- Female subject 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: Study to Evaluate the Pharmacokinetics, Safety, Tolerability of 100 mg Multiple Doses of GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.
Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls will be evaluated.
Read the detailed description
The study will be divided in two parts.
In Part 1, 3 subjects with severe renal impairment or end-stage renal disease (ESRD) not yet requiring dialysis (Group 1) will be recruited first. Thereafter, 3 subjects with normal renal function (Group 2) will be recruited. If a substantial effect on the PK in renal impaired subjects is observed on Day 10, the sponsor may elect to stop Part 1 of the study without enrolling the complete set of subjects and Part 2 will be initiated. In case no substantial effect on the PK is observed, 3 further subjects in both Group 1 and 2 will be recruited and analysed. If a substantial effect on the PK is observed, the study will proceed to Part 2. Part 2 of the study will not be conducted, if in Part 1 no substantial difference in PK is seen.
In Part 2, Group 3 (mild renal impairment) and Group 4 (moderate renal impairment) will be recruited first. After completion of the mild and moderate impairment groups, Group 5 (normal renal function) will be recruited.
- Conditions
- Renal Impairment
- Being tested
- GLPG0634
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0634Drug
Also called GLPG0634 tablets
100 mg oral tablet, intake once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Severe renal impairment | Experimental | Part 1 - Group 1: subjects with severe renal impairment or end-stage renal disease (ESRD), not on dialysis: Estimated glomerular filtration rate (eGFR) between 15-29 mL/min/1.73 m2 or <15 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days Receives: Drug: GLPG0634 |
| Part 1: Normal renal function | Experimental | Part 1 - Group 2: subjects with normal renal function: eGFR ≥90 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days Receives: Drug: GLPG0634 |
| Part 2 - Mild renal impairment | Experimental | Part 2 - Group 3: subjects with mild renal impairment: eGFR between 60-89 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days Receives: Drug: GLPG0634 |
| Part 2 - Moderate renal impairment | Experimental | Part 2 - Group 4:subjects with moderate renal impairment: eGFR between 30-59 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days Receives: Drug: GLPG0634 |
| Part 2 - Normal renal function | Experimental | Part 2 - Group 5: subjects with normal renal function: eGFR ≥90 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days Receives: Drug: GLPG0634 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Cmax of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Area under the plasma drug concentration-time curve over 24 hours (AUC0-24h)
AUC0-24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Secondary outcomes (15)
Cumulative amount excreted in urine expressed in μg and % of the dose administered (Ae)
Ae of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)
Renal clearance (CLR)
CLR (calculated as Ae/AUC, where Ae and AUC are calculated over the same interval) of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)
Plasma concentration observed at 24 h post-dose (C24h)
C24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Average plasma concentration (Cavg)
Cavg (calculated as AUC0-24h/24h) of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Time of occurrence of Cmax (tmax)
Tmax of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Area under the plasma drug concentration-time curve from zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-z)
AUC0-z of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Area under the plasma drug concentration-time curve, extrapolated to infinity (AUC0-∞)
AUC0-∞ of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Apparent terminal half-life (t1/2,λz)
t1/2,λz (calculated from (ln 2)/λz being the apparent terminal rate constant) of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Metabolite over parent ratio of AUC0-24h (R)
R (metabolite over parent ratio of AUC0-24h) after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Accumulation ratio (Rac)
Rac (calculated as AUC0-24h Day 10/AUC0-24h Day 1) after dosing in subjects with renal impairment versus subjects with normal renal function
Measured: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
The number of subjects with adverse events
To evaluate the safety and tolerability of GLPG0634 in subjects with renal impairment versus subjects with normal renal function 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 in subjects with renal impairment versus subjects with normal renal function 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 in subjects with renal impairment versus subjects with normal renal function 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 (ECG)
To evaluate the safety and tolerability of GLPG0634 in subjects with renal impairment versus subjects with normal renal function in terms of abnormal electrocardiogram (ECG)
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 in subjects with renal impairment versus subjects with normal renal function in terms of abnormal physical examination
Measured: From screening up to 10 days after last dose (Day 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02084199
- Sponsor's protocol ID
- GLPG0634-CL-106
- Other IDs
- 2013-004407-40
- Status last verified
- Jul 2014
- First submitted
- 9 Mar 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Pharmacokinetics, Safety, Tolerability of 100 mg Multiple Doses of GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT02084199
- Acronym / sponsor ID
- GLPG0634-CL-106
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Mar 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.
This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.
Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls will be evaluated.
Detailed description
The study will be divided in two parts.
In Part 1, 3 subjects with severe renal impairment or end-stage renal disease (ESRD) not yet requiring dialysis (Group 1) will be recruited first. Thereafter, 3 subjects with normal renal function (Group 2) will be recruited. If a substantial effect on the PK in renal impaired subjects is observed on Day 10, the sponsor may elect to stop Part 1 of the study without enrolling the complete set of subjects and Part 2 will be initiated. In case no substantial effect on the PK is observed, 3 further subjects in both Group 1 and 2 will be recruited and analysed. If a substantial effect on the PK is observed, the study will proceed to Part 2. Part 2 of the study will not be conducted, if in Part 1 no substantial difference in PK is seen.
In Part 2, Group 3 (mild renal impairment) and Group 4 (moderate renal impairment) will be recruited first. After completion of the mild and moderate impairment groups, Group 5 (normal renal function) will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Severe renal impairment | Experimental | Drug: GLPG0634Part 1 - Group 1: subjects with severe renal impairment or end-stage renal disease (ESRD), not on dialysis: Estimated glomerular filtration rate (eGFR) between 15-29 mL/min/1.73 m2 or <15 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days |
| Part 1: Normal renal function | Experimental | Drug: GLPG0634Part 1 - Group 2: subjects with normal renal function: eGFR ≥90 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days |
| Part 2 - Mild renal impairment | Experimental | Drug: GLPG0634Part 2 - Group 3: subjects with mild renal impairment: eGFR between 60-89 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days |
| Part 2 - Moderate renal impairment | Experimental | Drug: GLPG0634Part 2 - Group 4:subjects with moderate renal impairment: eGFR between 30-59 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days |
| Part 2 - Normal renal function | Experimental | Drug: GLPG0634Part 2 - Group 5: subjects with normal renal function: eGFR ≥90 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female white subjects between 18-79 years of age (inclusive)
- Subjects must have a BMI between 18-34 kg/m², inclusive
- Part 1, Group 1: subject with severe renal impairment or ESRD, not on dialysis : eGFR between 15-29 mL/min/1.73 m2 or <15 mL/min/1.73m²
- Part 1, Group 2: subject with normal renal function: eGFR ≥90 mL/min/1.73m²
- Part 2, Group 3: subject with mild renal impairment: eGFR between 60-89 mL/min/1.73 m²
Key exclusion criteria (6 listed)
- A subject with a known hypersensitivity to ingredients of the study medication or a significant allergic reaction to any drug
- Subject has previously participated in a GLPG0634 study or has previously received GLPG0634
- Concurrent participation or participation within 8 weeks 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
- A subject who has a current child wish
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 |
|---|---|---|
| GLPG0634Also: GLPG0634 tablets100 mg oral tablet, intake once daily for 10 days | Drug | Part 1 - Severe renal impairment, Part 1: Normal renal function, Part 2 - Mild renal impairment, Part 2 - Moderate renal impairment, Part 2 - Normal renal function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Cmax of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
Area under the plasma drug concentration-time curve over 24 hours (AUC0-24h)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
AUC0-24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
15 secondary outcomes
Cumulative amount excreted in urine expressed in μg and % of the dose administered (Ae)
Time frame: Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)
Renal clearance (CLR)
Time frame: Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)
Plasma concentration observed at 24 h post-dose (C24h)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Average plasma concentration (Cavg)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Time of occurrence of Cmax (tmax)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Area under the plasma drug concentration-time curve from zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-z)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Area under the plasma drug concentration-time curve, extrapolated to infinity (AUC0-∞)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Apparent terminal half-life (t1/2,λz)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Metabolite over parent ratio of AUC0-24h (R)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
Accumulation ratio (Rac)
Time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)
The number of subjects with adverse events
Time frame: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal laboratory parameters
Time frame: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal vital signs
Time frame: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal electrocardiogram (ECG)
Time frame: From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal physical examination
Time frame: From screening up to 10 days after last dose (Day 20)
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 Jul 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 in people with Renal Impairment, run by Lakefront Biotherapeutics NV at 1 site in Germany.
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 8 inclusion and 6 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 Jul 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 Germany. 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. 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?
Maximum observed plasma concentration (Cmax) (time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)). 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 22 Jul 2014.