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

NCT03812198 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-07-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Medical Expert · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2019-06-13
Completion
2019-06-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812198 on ClinicalTrials.gov