A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects

NCT02753218 | Terminated Phase 1

• 1 other identifier: LP0058-1267
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC) of midazolam on Day 17

  17 days

• Peak Plasma Concentration (Cmax) of midazolam on Day 17

  17 days

Secondary Outcomes (3)

• AUC of midazolam on Day 1

  1 day

• Cmax of midazolam on Day 1

  1 day

• Incidence and severity of adverse events (AEs) defined as spontaneously reported AEs and clinically significant values reported as AEs

  54 days

Study Arms (1)

Midazolam and LEO 32731

EXPERIMENTAL

Drug: Midazolam; Drug: LEO 32731

Interventions

Midazolam DRUG

Midazolam and LEO 32731

LEO 32731 DRUG

Midazolam and LEO 32731

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will, prior to any study-related activities, have given their written informed consent to participate in the study and to abide by the study restrictions.
• caucasian
• between 18 and 59 years of age, inclusive
• Subjects will have a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
• Subjects must be of good health

You may not qualify if:

• Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as condom with spermicidal foam/gel/film/cream/suppository), or who are not willing to refrain from donating sperm from the time of the first dose until 3 months after the final dosing occasion.
• Male subjects whose partners are of child bearing potential must also agree to use an additional highly effective method of contraception
• Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
• Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration of midazolam.
• Subjects who have received any medications, including St John's Wort (or other dietary restriction), known to chronically alter drug absorption or elimination processes (change enzyme levels) within 30 days of the first dose administration of midazolam.
• Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within the past 3 months prior to the first dosing occasion.
• Subjects who have donated any blood, plasma or platelets in 3 months prior to screening or who have made donations on more than 2 occasions within the 12 months preceding the first dose administration of midazolam.
• Subjects with a significant history of drug allergy as determined by the Investigator.
• Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
• Subjects who have a supine blood pressure and supine pulse rate at screening higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 45 bpm, respectively.
• Subjects who consume more than 28 units of alcohol per week.
• Subjects who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator.
• Subjects with a positive urine drugs of abuse screen or alcohol breath test result at screening or first admission.
• Subjects who smoke or who have smoked in the 3 months prior to first dose administration.
• Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Covance Clinical Research Unit Ltd., Springfield House, Hyde Street

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

GB (1)