To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

• ClinicalTrials.gov Identifier: NCT02093819
• Recruitment Status: Completed
• First Posted: March 21, 2014
• Results First Posted: March 22, 2016
• Last Update Posted: March 22, 2016
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Placebo to BI 416970; Drug: BI 416970	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 416970 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, Investigation of Relative Bioavailability of BI 416970 (Open-label, Randomised, Three-way Cross-over) and Assessment of Safety and Exposure of BI 416970 in CYP2C9 Genotyped Volunteers (Open-label, Single-dose)
• Study Start Date: April 2014
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI 416970 single rising dose part; single rising dose given as tablet	Drug: Placebo to BI 416970; single rising doses; Drug: BI 416970; single rising doses

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With Drug-related Adverse Events [ Time Frame: AEs were recorded throughout the trial ]
   Percentage of subjects with drug-related adverse events

Secondary Outcome Measures :

1. Cmax (Maximum Measured Concentration of the Analyte in Plasma) [ Time Frame: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration ]
   Cmax (maximum measured concentration of the analyte in plasma)
2. AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) [ Time Frame: 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration ]
   AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Eligibility Criteria

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

Criteria

Inclusion criteria:

• Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
• Age 18 to 50 years (incl.)
• Body Mass Index 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
• Known genotype of CYP2C9 isoenzyme

Exclusion criteria:

• Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 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
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders

Contacts and Locations

Locations

Germany

1345.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02093819
• Other Study ID Numbers: 1345.1; 2013-003560-31 ( EudraCT Number: EudraCT )
• First Posted: March 21, 2014
• Results First Posted: March 22, 2016
• Last Update Posted: March 22, 2016
• Last Verified: February 2016