Safety Tolerability and Pharmacokinetic of BI 409306
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Placebo (Drug); Placebo . (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug); BI 409306 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The primary objective of the current study is to investigate the safety and tolerability of
BI 409306 in healthy male genotyped volunteers following oral administration of single
rising doses.
The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate
release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when
administered as immediate release solid oral dosage compared to oral drinking solution and
(3) to compare the safety and pharmacokinetic profiles between two different groups of
genotyped subjects.
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Physical examination (respiratory, gastro-intestinal, musculoskeletal)Vital signs 12-lead ECG (electrocardiogram) Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets) Number of Participants with Adverse Events as a Measure of Safety and Tolerability Assessment of tolerability by investigator Clinical laboratory tests (clinical chemistry: electrolytes;liver enzymes, bilirubin, amylase, lipase, cholesterol) Clinical laboratory tests (urinanalysis: pH, nitrite, protein, glucose, ketones, red blood cells, white blood cells, bacteria, crystals) Changes from baseline in Bond-Lader Visual Analogue Scales
Secondary outcome: Cmax (maximum measured concentration of the analyte in plasma)AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point) Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Eligibility
Minimum age: 21 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion criteria:
1. 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
2. Age > 21 and Age < 50 years
3. Body Mass Index (BMI) > 18. 5 and BMI < 29. 9 kg/m2
Exclusion criteria:
1. Any finding of the medical examination (including BP, PR and ECG) deviating from
normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of
seizures, stroke or psychiatric disorders) within the past 6 month
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its
excipients)
9. 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
10. Any laboratory value outside the reference range that is of clinical relevance
11. A marked baseline prolongation of QT/QTc interval (e. g., repeated demonstration of a
QTc interval >450 ms);
12. A history of additional risk factors for Torsades de points (TdP) (e. g., heart
failure, hypokalemia, family history of Long QT Syndrome)
Locations and Contacts
1289.1.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany
Additional Information
Starting date: April 2011
Last updated: October 31, 2013
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