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

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 - LAS191954 SAD/MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42989

Enrollment

Registered

2016-04-18

Start date

2016-05-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Part 1: The study will consist of 3 periods during which the volunteer will receive LAS191954 or placebo once per period. LAS191954 and placebo will be given as oral capsules. Part 2: The study wi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- To evaluate safety and tolerability of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers. - To evaluate the pharmacokinetics of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers. - To evaluate the pharmacodynamic effects of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers.	—

Measure

Time frame

- To evaluate safety and tolerability of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers. - To evaluate the pharmacokinetics of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers. - To evaluate the pharmacodynamic effects of LAS191954 administered orally as a single dose and as multiple doses in healthy male volunteers.

—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)