Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers

NCT02652416 | Completed Phase 1 Results

• 1 other identifier: 1320.23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Drug-related Adverse Events (AEs)

  The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.

  From first drug administration to 4 days after last drug intake, up to 19 days.

Secondary Outcomes (8)

• Cmax

  -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.

• Tmax

  -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.

• AUC0-12

  -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.

• AUC0-infinity

  -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.

• t1/2

  -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.

Study Arms (6)

SRD part (low dose)

EXPERIMENTAL

Chinese, Japanese both

Drug: BI 1026706

SRD part (medium dose)

EXPERIMENTAL

Chinese, Japanese both

Drug: BI 1026706

SRD part (high dose)

EXPERIMENTAL

Chinese, Japanese both

Drug: BI 1026706

MD part (high dose)

EXPERIMENTAL

Chinese, Japanese both

Drug: BI 1026706

Placebo (SRD part)

EXPERIMENTAL

placebo

Drug: Placebo

Placebo (MD part)

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

BI 1026706 DRUG

oral administration

MD part (high dose); SRD part (high dose); SRD part (low dose); SRD part (medium dose)

Placebo DRUG

placebo

Placebo (MD part); Placebo (SRD part)

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 (BP, PR), 12-lead ECG, and clinical laboratory tests
• Chinese ethnicity 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 were all born in Japan
• Age of 20 to 45 years (incl.) - BMI of 18.5 to 25 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study 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 30 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

You may not qualify if:

• Any finding in the medical examination (including BP, PR or 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 T-SPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
• 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 10 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 (1)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, 812-0025, Japan

Location

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 11, 2016
• Study Start: September 16, 2016
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-04

Locations

JP (1)