drugset / Trial / NCT03995550

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

NCT03995550 ↗

Phase 1 Withdrawn LEO Pharma
RandomizedParallel-groupTriple-blindTreatment

Summary

This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people. The trial consists of 2 parts: * In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups. * In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups. Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.

Timeline

Start
2019-07-03
Primary completion
2020-01-27
Completion
2020-07-16

Outcome

Outcome not reported

Stopped (Business): “Portfolio proritisation”

Drugs

EvaluationDrugModalityDoseRoute
Subject LEO 142397 Unknown — —

Indications

No indication recorded.