Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers

NCT02331277 | Completed Phase 1 Results

• 1 other identifier: 1293.9
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers. The secondary objective is the exploratory evaluation of the pharmacokinetics and pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Drug-related Adverse Events.

  Percentage of subjects with drug-related adverse events (AEs). Medical judgment was used to determine the relationship between study medication and AEs, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

  From the first drug administration until 126 days after last drug administration, up to 148 days.

Secondary Outcomes (8)

• Maximum Measured Concentration of BI 655064 in Plasma After the 1st Dose (Cmax)

  Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 hours (h) after first drug administration on day 1.

• Time From Dosing to Maximum Measured Concentration of BI 655064 in Plasma After the 1st Dose (Tmax)

  Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.

• Area Under the Concentration-time Curve of BI 655064 in Plasma After the 1st Dose Over a Uniform Dosing Interval τ (AUCτ,1)

  Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h after first drug administration on day 1.

• Maximum Measured Concentration of BI 655064 in Plasma After the 4th Dose (Cmax,4)

  Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.

• Time From Dosing to Maximum Measured Concentration of BI 655064 in Plasma After the 4th Dose (Tmax,4)

  Pharmacokinetic samples were collected at 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520 and 3192 h after fourth drug administration on day 22.

Study Arms (2)

BI 655064

EXPERIMENTAL

Subjects received BI 655064 240 milligram (mg) via subcutaneous injection every week, until 4 weeks.

Drug: BI 655064

Placebo

PLACEBO COMPARATOR

Subjects received placebo matching to BI 655064 via subcutaneous injection every week, until 4 weeks.

Drug: Placebo

Interventions

BI 655064 DRUG

subcutaneous injection

BI 655064

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Echocardiogram, and clinical laboratory tests
• Chinese ethnicity according to the following criteria:
• Ethnic 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
• Age within the range of 20 to 45 years inclusive
• Body Mass Index within the range of 18.5 and 25 kg/m2 inclusive
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
• Male subjects who
• are documented to be sterile or consistently and correctly use a condom while their female partners (if of childbearing potential) agree to use any of the following adequate contraception methods: implants, injectables, combined oral contraceptives, intrauterine device (IUD) from the date of screening until at least 6 months after the last dose of BI 655064 taken in the current trial.
• do not donate any sperm sample for procreation purposes, from the date of screening until at least 6 months after last dose of BI 655064 taken in the current trial.
• It is the responsibility of the male subject to ensure that his partner does not become pregnant during all the study duration.

You may not qualify if:

• Any finding in the medical examination (including Blood pressure, Pulse rate or Echocardiogram) deviating from normal and judged 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 clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
• Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (consumption of more than 20 g/day)
• Drug abuse or positive drug screen
• Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1293.9.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

MeSH Terms

Interventions

BI 655064

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 6, 2015
• Study Start: September 1, 2015
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)