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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 655064; Drug: Placebo

• Registration Number: NCT02331277
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Study Start: 2015-09-01
• Primary Completion: 2016-05-25
• Study Completion: 2016-05-25
• Status Verified: 2022-09
• Results First Submitted: 2022-09-26
• Results First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 655064	BI 655064	Subjects received BI 655064 240 milligram (mg) via subcutaneous injection every week, until 4 weeks.
Placebo	Placebo	Subjects received placebo matching to BI 655064 via subcutaneous injection every week, until 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events.	From the first drug administration until 126 days after last drug administration, up to 148 days.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Time from dosing to maximum measured concentration of BI 655064 in plasma after the 1st dose (tmax).
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.	Maximum measured concentration of BI 655064 in plasma after the 1st dose (Cmax).
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.	Area under the concentration-time curve of BI 655064 in plasma after the 1st dose over a uniform dosing interval τ (= 1 week) (AUCτ,1).
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.	Time from dosing to maximum measured concentration of BI 655064 in plasma after the 4th dose (tmax,4).
Area Under the Concentration-time Curve of BI 655064 in Plasma After the 4th Dose Over a Uniform Dosing Interval τ (AUCτ,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.	Area under the concentration-time curve of BI 655064 in plasma after the 4th dose over a uniform dosing interval τ (= 1 week) (AUCτ,4).
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.	Maximum measured concentration of BI 655064 in plasma after the 4th dose (Cmax,4).
Accumulation Ratio of BI 655064 in Plasma After Administration of the 4th Dose Over the Dosing Interval τ, Expressed as Ratio of AUC After the 4th Dose and After the 1st Dose (RA,AUC,4)	Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for AUCτ,1 and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for AUCτ,4.	Accumulation ratio of BI 655064 in plasma after administration of the 4th dose over the dosing interval τ (= 1 week), expressed as ratio of AUC after the 4th dose and after the 1st dose (RA,AUC,4).
Accumulation Ratio of BI 655064 in Plasma After Administration of the 4th Dose Over the Dosing Interval τ, Expressed as Ratio of Cmax After the 4th Dose and After the 1st Dose (RA,Cmax,4)	Pharmacokinetic samples were collected at -3, 8, 12, 24, 48, 72, 84, 96, 108, 120, 144 and 167.5 h for Cmax and 505, 516, 528, 552, 576, 600, 624, 648, 672, 696, 744, 816, 912, 1008, 1176, 1344, 1512, 1848, 2520, 3192 and 5880 h for Cmax,4.	Accumulation ratio of BI 655064 in plasma after administration of the 4th dose over the dosing interval τ (= 1 week), expressed as ratio of Cmax after the 4th dose and after the 1st dose (RA,Cmax,4).

Trial Locations

Locations (1)

1293.9.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of