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Completed

NCT Number: NCT01146886

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

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)

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1283.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male volunteers

Treatment and study plan

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

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

Primary outcomes

  1. Change from baseline in Physical examination (occurrence of findings)

    Time frame: up to 14 days post treatment

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

    Time frame: up to 14 days post treatment

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

    Time frame: up to 14 days post treatment

  4. Cardiopulmonary monitoring resulting in clinically relevant findings

    Time frame: up to 14 days post treatment

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

    Time frame: up to 14 days post treatment

  6. Number of patients with Adverse events (AE)

    Time frame: up to 14 days post treatment

  7. Assessment of tolerability by the investigator

    Time frame: up to 14 days post treatment

Secondary outcomes

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

    Time frame: up to 72 hours post treatment

  2. (5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition

    Time frame: up to 24h

  3. 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)

    Time frame: up to 72 hours post treatment

  4. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 72 hours post treatment

  5. tmax (time from dosing to maximum measured concentration)

    Time frame: up to 72 hours post treatment

  6. %AUCtz-∞ (percentage of the AUC0-∞ that was obtained by extrapolation)

    Time frame: up to 72 hours post treatment

  7. λz (terminal rate constant in plasma)

    Time frame: up to 72 hours post treatment

  8. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: up to 72 hours post treatment

  9. MRToral (mean residence time of the analyte in the body after oral administration)

    Time frame: up to 72 hours post treatment

  10. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)

    Time frame: up to 72 hours post treatment

  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: up to 72 hours post treatment

  12. Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only

    Time frame: up to 72 hours post treatment

  13. fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only

    Time frame: up to 72 hours post treatment

  14. CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[

    Time frame: up to 72 hours post treatment

  15. UFF/UFE ratio as an indicator of 11β-HSD2 inhibition

    Time frame: up to 24h

  16. Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis

    Time frame: up to 24h

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
First posted
Jun 22, 2010
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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