Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers

NCT01146886 | Completed Phase 1

• 2 other identifiers: 1283.12010-018856-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (7)

• Change from baseline in Physical examination (occurrence of findings)

  up to 14 days post treatment

• Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR])

  up to 14 days post treatment

• Change from baseline in 12-lead ECG with special attention to QTc prolongation

  up to 14 days post treatment

• Cardiopulmonary monitoring resulting in clinically relevant findings

  up to 14 days post treatment

• Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland

  up to 14 days post treatment

• Number of patients with Adverse events (AE)

  up to 14 days post treatment

• Assessment of tolerability by the investigator

  up to 14 days post treatment

Secondary Outcomes (16)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours post treatment

• (5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition

  up to 24h

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 72 hours post treatment

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours post treatment

• tmax (time from dosing to maximum measured concentration)

  up to 72 hours post treatment

Study Arms (2)

BI 135585

EXPERIMENTAL

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

Placebo to BI 135585

PLACEBO COMPARATOR

1 single dose per subject as oral solution in Part 1

Drug: Placebo to BI 135585

Interventions

Placebo to BI 135585 DRUG

Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1

Placebo to BI 135585

BI 135585 DRUG

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

BI 135585

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- healthy male volunteers

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1283.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-(2-hydroxy-2-methylpropyl)-3-(1-(4-(1-methyl-2-oxo-1,2-dihydropyridin-4-yl)phenyl)ethyl)-6-phenyl-1,3-oxazinan-2-one

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (1)