A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)

NCT02199873 Phase 1 COMPLETED

The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	1998-06

Conditions

• Healthy

Interventions

• BIIX 1 XX - single rising dose
• Placebo

Primary outcomes

• Number of subjects with adverse events — up to 3 months
• Number of subjects with abnormal changes in laboratory parameters — up to 8 days after last drug administration
• Change in impedance cardiography — up to 30 minutes after drug administration
• Change in cutaneous microcirculation — up to 30 minutes after drug administration