Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 409306; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611311

1289.17

2012-000052-34 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male/female subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 6 patient groups, including a placebo group

Placebo (Young subjects)

Placebo Comparator group

Description:

Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Treatment:

Drug: Placebo

BI 409306 - 25 milligram (mg) (Young subjects)

Experimental group

Description:

Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Treatment:

Drug: BI 409306

BI 409306 - 50 milligram (mg) (Young subjects)

Experimental group

Description:

Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Treatment:

Drug: BI 409306

Placebo (Elderly subjects)

Placebo Comparator group

Description:

Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days

Treatment:

Drug: Placebo

BI 409306 - 25 milligram (mg) (Elderly subjects)

Experimental group

Description:

Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Treatment:

Drug: BI 409306

BI 409306 - 50 milligram (mg) (Elderly subjects)

Experimental group

Description:

Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Treatment:

Drug: BI 409306