A two-part, phase 1, randomized, single blind, placebo-controlled, single centre study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAS191954 following oral administration of single and multiple ascending doses in healthy male volunteers

Completed

Conditions: pemphigus vulgaris (auto-immune intradermal blistering disease)
autoimmune and blistering disease
dermatological

Registration Number: NL-OMON42989

Lead Sponsor: Almirall

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- willing to participate in this study
- healthy Caucasian male
- age between 18 and 45 years of age, inclusive
- BMI between 18.5 and 29.9 kilograms/meter2
- do not smoke and did not smoke during at least 6 months prior to the pre-study screening. Able to abstain from smoking from admission to the clinical research center and during stay in the clinical research center
- at the pre-study screening state of health must satisfy the study entry requirements

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To evaluate safety and tolerability of LAS191954 administered orally as a<br /><br>single dose and as multiple doses in healthy male volunteers.<br /><br>- To evaluate the pharmacokinetics of LAS191954 administered orally as a single<br /><br>dose and as multiple doses in healthy male volunteers.<br /><br>- To evaluate the pharmacodynamic effects of LAS191954 administered orally as a<br /><br>single dose and as multiple doses in healthy male volunteers.</p><br>

Secondary Outcome Measures