Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers

NCT01348165 | Terminated Phase 1 Results

• 2 other identifiers: 1306.12010-023462-52
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of Subjects With Drug Related Adverse Events

  Number of subjects with drug related adverse events (AEs)

  From baseline up to 28 days

• Blood Pressure

  Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)

  Baseline and 28 days

• Pulse Rate (PR)

  Change from Baseline to 28 Days in Pulse Rate

  Baseline and 28 days

• Respiratory Rate (RR)

  Change from Baseline to 28 Days in Respiratory rate (RR)

  Baseline and 28 days

• Body Temperature

  Change from baseline to 28 Days in Body temperature

  Baseline and 28 days

• Assessment of Tolerability by Investigator

  The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.

  28 days

Secondary Outcomes (17)

• Maximum Measured Concentration (Cmax)

  30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration

• Time to Maximum Measured Concentration (Tmax)

  30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration

• Area Under the Curve 0 to Infinity (AUC0-infinity)

  30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration

• Terminal Half-life (t1/2)

  30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration

• Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

  30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration

Study Arms (10)

BI 137882 Dose 1

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 2

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 3

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 4

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 5

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 6

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 7

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 8

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

BI 137882 Dose 9

EXPERIMENTAL

Powder for oral solution

Drug: BI 137882

Placebo

PLACEBO COMPARATOR

Powder for oral solution

Drug: Placebo

Interventions

BI 137882 DRUG

Powder for oral solution

BI 137882 Dose 1; BI 137882 Dose 2; BI 137882 Dose 3; BI 137882 Dose 4; BI 137882 Dose 5; BI 137882 Dose 6; BI 137882 Dose 7; BI 137882 Dose 8; BI 137882 Dose 9

Placebo DRUG

Powder for oral solution

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age 21 to 50 years
• BMI 18.5 to 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes /day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 20 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Limitations and Caveats

The trial was put on hold due to a serious adverse event (post-treatment period) which was evaluated to be not drug related and the trial was subsequently terminated.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Last Updated: September 16, 2016
• Results First Posted: June 4, 2014

Record last verified: 2016-08