NCT03812198

A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People

A Phase 1, 3-part, Single (Open-label) and Multiple (Double-blind, Placebo-controlled) Oral Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of LEO 32731 Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4 different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in 3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will participate in 3 treatment periods.

Detailed description

Part 1 will evaluate the pharmacokinetics of single doses of 4 test formulations of LEO 32731 compared with a reference formulation. Part 2 will evaluate the effect of food on the pharmacokinetics of selected test formulations of LEO 32731. Part 3 will evaluate the tolerability and safety of selected test formulations of LEO 32731 after multiple dosing. Based on data from Part 1, up to 3 formulations will be taken forward to Part 2. If none of the formulations are considered appropriate to take forward to Part 2, the trial will stop after Part 1. Similarly, based on data from Part 2, up to 2 formulations will be taken forward to Part 3. If none of the formulations are considered appropriate to take forward to Part 3, the trial will stop after Part 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LEO 32731 modified release tablet	At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.
DRUG	LEO 32731 blend, hard capsule	At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
DRUG	LEO 32731 API, hard capsule	At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
DRUG	LEO 32731 soft capsule	At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
DRUG	LEO 32731 gastro-resistant capsule	At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
DRUG	LEO 32731	At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
OTHER	Placebo	At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-06-13
• Completion: 2019-06-13
• First posted: 2019-01-23
• Last updated: 2019-07-01

Locations

1 site across 1 country: United Kingdom