First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187
This study has been completed.
Sponsor:
Galapagos NV
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT00928343
First received: June 23, 2009
Last updated: January 14, 2010
Last verified: January 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 23, 2009 | ||||||||
| Last Updated Date | January 14, 2010 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Safety and tolerability of single subcutaneous and oral dosing [ Time Frame: up to day 10 postdose ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00928343 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187 | ||||||||
| Official Title ICMJE | Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects. | ||||||||
| Brief Summary | The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 18 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00928343 | ||||||||
| Other Study ID Numbers ICMJE | GLPG0187-CL-101 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Senior Vice President Development, Galapagos NV | ||||||||
| Study Sponsor ICMJE | Galapagos NV | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Galapagos NV | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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