Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01971502
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo to BI 1060469; Drug: BI 1060469; Drug: BI 1060469	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of BI 1060469 in Healthy Male Volunteers (Single-blind, Placebo-controlled, Randomised, Partly Fixed-sequence, Parallel Group Design) and Effect of Food on the Bioavailability of BI 1060469 (Open-label, Randomised, Two-way Cross-over)
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1060469 single rising dose part single rising doses given as tablet	Drug: Placebo to BI 1060469; single rising doses; Drug: BI 1060469; single rising doses
Experimental: BI 1060469 food effect part given as tablet fasted and fed	Drug: BI 1060469; food effect

Outcome Measures

Primary Outcome Measures

1. Number of subjects with drug- related adverse events. [up to 2 weeks]

Secondary Outcome Measures

1. Cmax (maximum measured concentration of BI 1060469 in plasma) [up to 2 weeks]

2. AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity) [up to 2 weeks]

3. AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point) [up to 2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests

2. Age within the range of 18 to 50 years

3. Body mass index within the range of 18.5 and 29.9 kg/m2

4. Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.

2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

3. In the SRD: serum creatinine laboratory value outside the normal range

4. Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula < 60 ml/ min

5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)

6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1333.1.1 Boehringer Ingelheim Investigational Site	Biberach		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01971502
• Other Study ID Numbers: 1333.1; 2013-001475-20
• First Posted: Oct 29, 2013
• Last Update Posted: Oct 27, 2014
• Last Verified: Jul 1, 2014

Study Results

No Results Posted as of Oct 27, 2014