Safety of Single Rising Doses and Relative Bioavailability of BI 691751

NCT01843972 | Completed Phase 1 Results

• 2 other identifiers: 1334.12012-005721-67
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I). To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUC0-72h (Part II)

  AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration

• Cmax (Part II)

  Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration

• Frequency of Subjects With Drug-related Adverse Events (Part I)

  Frequency of subjects with drug-related Adverse Events (AEs) (Part I)

  Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7

Secondary Outcomes (5)

• Cmax (Part I)

  for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

• AUC0-infinity (Part I)

  for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

• AUC0-tz

  Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h

• t1/2 (Part I)

  for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

• Tmax (Part I)

  for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Study Arms (10)

BI 691751 dose 2 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751 dose 3 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751 dose 4 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751 dose 5 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751 dose 6 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751 dose 7 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

BI 691751dose 1 (part I)

EXPERIMENTAL

single dose given as oral solution

Drug: BI 691751

Placebo (part I)

PLACEBO COMPARATOR

placebo solution

Drug: Placebo

BI 691751 tablet (part II)

EXPERIMENTAL

single dose given as 1 tablet

Drug: BI 691751

BI 691751 solution (part II)

ACTIVE COMPARATOR

single dose given as oral solution

Drug: BI 691751

Interventions

BI 691751 DRUG

oral solution BI 691751, dose 6

BI 691751 dose 6 (part I)

Placebo DRUG

placebo solution

Placebo (part I)

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects
• Subjects must be able to understand and comply with study requirements
• Age from 18 to 55 years
• BMI range: from 18.5 to 29.9 kg/m2
• Known genotype as specified in the study protocol

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1334.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 27, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-05

Locations

DE (1)