This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated

NCT03259464 | Completed Phase 1

• 1 other identifier: 1366-0013
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number [N (%)] of subjects with drug-related Adverse Events (AEs)

  up to day 35

Secondary Outcomes (4)

• After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)

  up to 24 hours

• After the first dose:Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours

• After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]

  Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours

• After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)

  Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours

Study Arms (2)

BI 685509

EXPERIMENTAL

Chinese \& Japanese subjects

Drug: BI 685509

Placebo

PLACEBO COMPARATOR

Chinese \& Japanese subjects

Drug: Placebo

Interventions

BI 685509 DRUG

3 sequential dose groups

BI 685509

Placebo DRUG

3 sequential dose groups

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Chinese or Japanese ethnicity, according to the following criteria:
• Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
• Japanese; born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
• Age of 20 to 45 years (incl.)
• Body mass index (BMI) range: ≥18.5 and \<25.0 kg/m2
• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
• Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after trial completion:
• Use of adequate contraception, e.g. any of the following methods plus condom: combined oral contraceptives, intrauterine device
• Vasectomised (vasectomy at least 1 year prior to enrolment)
• Surgically sterilised (including hysterectomy) female partner
• Sexually abstinent

You may not qualify if:

• Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• 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 (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections including HIV, viral hepatitis and (or) tuberculosis or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold (or TSPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test will not participate in the study. The HBV carriers and subjects with history of HB (including the subjects with only HBs antibody positive \[negative for both HBs antigen and HBc antibody\] and without HB vaccination) will not be allowed to participate in this trial.
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of biologic agents other than current study medication or drugs considered likely to interfere with the safe conduct of the study
• Within 30 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial (including bioequivalence trial) with an investigational drug within 90 days or 5 half-lives (whichever is greater) prior to planned administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g per day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 133-0004, Japan

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 23, 2017
• Study Start: September 4, 2017
• Primary Completion: May 26, 2018
• Study Completion: May 26, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

KR (1); JP (1)