Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01146886
First received: June 14, 2010
Last updated: June 1, 2011
Last verified: June 2011
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Purpose
The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2)
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Placebo to BI 135585 Drug: BI 135585 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 10 mg to 1200 mg of BI 135585 XX Administered as a Solution to Healthy Male Volunteers (Trial Part 1), Followed by an Open, Randomised, Single-dose, Intra-individual Bioavailability Comparison of 200 mg BI 135585 XX as Tablet and as Solution (Trial Part 2) |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Safety and tolerability of BI 135585 XX will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, ECGs, cardiopulmonary monitoring, laboratory tests, and incidence and severity of adverse events. [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To characterize the pharmacokinetics of BI 135585 XX in plasma and urine following oral administration [ Time Frame: up to 72 hours post treatment ] [ Designated as safety issue: No ]
- To assess the pharmacodynamics of BI 135585XX by measuring of cortisol and cortisone and their metabolites in urine [ Time Frame: up to 24 hours post treatment ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI 135585
1 single dose per subject as oral solution in Part 1, or 3 single doses per subject as oral solution and 2 different tablet formulations in Part 2
|
Drug: BI 135585
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1
|
|
Placebo Comparator: Placebo to BI 135585
1 single dose per subject as oral solution in Part 1
|
Drug: Placebo to BI 135585
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- healthy male volunteers
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146886
Locations
| Germany | |
| 1283.1.1 Boehringer Ingelheim Investigational Site | |
| Biberach, Germany | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01146886 History of Changes |
| Other Study ID Numbers: | 1283.1, 2010-018856-28 |
| Study First Received: | June 14, 2010 |
| Last Updated: | June 1, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013