Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Asthma; Rhinitis, Allergic, Perennial

Treatments: Drug: placebo; Drug: BI 671800

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216384

1268.15

Details and patient eligibility

About

The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.

Enrollment: 73 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy
2. Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
3. Age >= 20 and age =< 50
4. Body Mass Index (BMI) >=18.5 and BMI =< 25 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

BI 671800 active

Experimental group

Description:

SRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose. MRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose followed by multiple doses with a PK sampling interval in between.

Treatment:

Drug: BI 671800

Placebo

Placebo Comparator group

Description:

3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part

Treatment:

Drug: placebo