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Completed

NCT Number: NCT02305901

The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers

To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1307.20.1 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 subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  • Age of 18 to 55 years (incl.)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Further exclusion criteria may apply.

Treatment and study plan

repaglinide

Drug

single dose on day 1 of visits 2 and 3

BI 187004 tablet

Drug

multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3

bupropion extended release tablet

Drug

single dose on day 3 of visits 2 and 3

Primary outcomes

  1. Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point

    Time frame: up to 48 h post dose

  2. Maximum measured concentration of repaglinide in plasma

    Time frame: up to 48 h post dose

  3. Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point

    Time frame: up to 119 h post dose

  4. Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point

    Time frame: up to 119 h post dose

  5. Maximum measured concentration of total bupropion in plasma

    Time frame: up to 119 h post dose

  6. Maximum measured concentration of S-bupropion in plasma

    Time frame: up to 119 h post dose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion Following Oral Administration in Healthy Male Subjects (an Open-label, One-sequence Trial)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
May 12, 2015

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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