Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006415

Trial Description

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Title

Study to Evaluate the Pharmacokinetics, Safety, Tolerability of 100 mg Multiple Doses of GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006415
  •   2014/10/30
  •   2014/03/09
  •   no
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Secondary IDs

  •   2013-004407-40 
  •   NCT02084199  (ClinicalTrials.gov)
  •   GLPG0634-CL-106  (Galapagos NV)
  •   2013-004407-40 
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Health Condition or Problem studied

  •   Renal Impairment
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: GLPG0634
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   I
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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

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Secondary Outcome

- 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); Ae of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
- Renal clearance (CLR); time frame: Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12); 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
- 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); C24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
- 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); 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
- 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); Tmax 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 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); AUC0-z 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, 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); AUC0-∞ of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
- 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); 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
- 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); R (metabolite over parent ratio of AUC0-24h) after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function
- Accumulation ratio (Rac); time frame: Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17); Rac (calculated as AUC0-24h Day 10/AUC0-24h Day 1) after dosing in subjects with renal impairment versus subjects with normal renal function
- 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 in subjects with renal impairment versus subjects with normal renal function 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 in subjects with renal impairment versus subjects with normal renal function 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 in subjects with renal impairment versus subjects with normal renal function in terms of abnormal vital signs
- The number of subjects with abnormal electrocardiogram (ECG); time frame: From screening up to 10 days after last dose (Day 20); 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)
- 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 in subjects with renal impairment versus subjects with normal renal function in terms of abnormal physical examination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/03/31
  •   30
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   79   Years
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Additional Inclusion Criteria

- 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


- 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

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Exclusion Criteria

- 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

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Addresses

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    • Galapagos NV
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    • Galapagos NV
    • Pille Harrison, MD 
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    • Galapagos NV
    • Pille Harrison, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/11/05


* This entry means the parameter is not applicable or has not been set.