Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

June 28, 2021 updated by: LEO Pharma

A Phase 1, Single Centre Randomised, Double-blind Placebo-controlled Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.

This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary objective is the assessment of PK in Japanese subjects.

Data obtained from this trial will be used to compare with existing data from the other Phase 1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects will allow the inclusion of Japanese patients into Phase 2b studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
  2. An understanding, willingness and ability to fully comply with study procedures and restrictions.
  3. Japanese men aged >20 to <45 years (from date of signing informed consent which is defined as the beginning of the Screening Period). This inclusion criterion will only be assessed at the Screening Visit.
  4. Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.
  5. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m².

Exclusion Criteria:

  1. Current or recurrent disease (i.e. with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator) that could affect the action, absorption, or disposition of LEO 32731, or could affect clinical assessments or clinical laboratory evaluations.
  2. Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  3. Any history of psychiatric or mental health issue such (including depression) deemed clinically significant as assessed by the Investigator.
  4. Any history of/or active cancer or malignancy (other than squamous cell carcinoma more than 5 years prior).
  5. History of Wiskott-Aldrich Syndrome
  6. History of active tuberculosis, and/or history of partially or incomplete treatment of tuberculosis.
  7. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study.
  8. Use of any prescribed systemic or topical medication(s) within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period.
  9. Use of any systemic or topical non-prescribed or over-the-counter (OTC) medication(s) (including multivitamin, herbal, or homeopathic preparations) within 7 days or 5 half-lives (whichever is longer) prior to Day 1 of the dosing period. The occasional use of paracetamol (acetaminophen) is allowed to treat short term adverse events; subject to review by the investigator. The maximum allowed daily dose is 2000 mg for paracetamol at the discretion of the investigator.
  10. Consumption of more than 21 units of alcohol per week.
  11. History or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 21 units for males.
  12. Positive test results for alcohol, drugs of abuse at screening or Day -1.
  13. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch) within 90 days prior to Day 1 of the dosing period.
  14. Use of an investigational product within 90 days prior to Day 1 of the dosing period or active enrolment in another drug or vaccine clinical study.
  15. Known or suspected intolerance, hypersensitivity or allergy (excluding non-active hayfever) to any drug, food or other known substance (including investigational product, its closely related compounds, and/or any of the stated ingredients).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LEO 32731

Incremental dosing of LEO 32731 progressing to a maximum of 30 mg.

  • Days 1 - 3: 10 mg dose twice a day for three days
  • Days 4 - 6: 20 mg dose twice a day for three days
  • Days 7 - 11: 30 mg dose twice a day for five days
  • Days 12: 30 mg dose once in the morning
LEO 32731 is being developed by LEO Pharma.
PLACEBO_COMPARATOR: Placebo

Incremental dosing of placebo progressing to a maximum of 30 mg.

  • Days 1 - 3: 10 mg dose twice a day for three days
  • Days 4 - 6: 20 mg dose twice a day for three days
  • Days 7 - 11: 30 mg dose twice a day for five days
  • Days 12: 30 mg dose once in the morning
Placebo contains the same excipients in the same concentration, only lacking LEO 32731

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve from zero to 12 hour (AUC0-12) on day 12 of LEO 32731.
Time Frame: on Day 12
on Day 12
Time to reach maximum observed plasma concentration (tmax) on day 12 of LEO 32731.
Time Frame: on Day 12
on Day 12
Maximum observed plasma concentration (Cmax) on day 12 of LEO 32731.
Time Frame: on Day 12
on Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ulrike Lorch, MD, Richmond Pharmacology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 25, 2017

Primary Completion (ACTUAL)

August 22, 2017

Study Completion (ACTUAL)

August 22, 2017

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0058-1362
  • 2017-000907-26 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis Vulgaris

Clinical Trials on LEO 32731

Search Similar Trials