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

Healthy Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LEO 142397 in Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03995550
• Other study ID #: LP0184-1415
• Secondary ID: 2018-004470-10
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key inclusion Criteria:

• Body mass index of 18.0-32.0 kg/m2, inclusive.

• In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:

• Aspartate aminotransferase and alanine aminotransferase values =1.5 times the upper limit of normal.

• Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.

• Haemoglobin value, neutrophil count, and lymphocyte count = the lower limit of normal.

• Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.

• Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.

Key exclusion criteria:

• Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.

• Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.

• History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.

• Current active tuberculosis based on QuantiFERON-TB Gold test.

• Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.

• Electrocardiogram abnormalities at screening or check-in.

• Smoking of >10 cigarettes per day, on average, within the last 3 months.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LEO 142397
A compound in development by LEO Pharma A/S
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1. Number of treatment-emergent adverse events per subject		From Day 1 (postdose) up to Day 8
Primary	Part 1. Having clinically significant abnormalities in systolic blood pressure	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 8
Primary	Part 1. Having clinically significant abnormalities in diastolic blood pressure	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 8
Primary	Part 1. Having clinically significant abnormalities in heart rate	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 8
Primary	Part 1. Having clinically significant abnormalities in oral body temperature	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 8
Primary	Part 1. Having an abnormal ECG	ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or change from baseline of >30 msec	From Day 1 (postdose) up to Day 8
Primary	Part 2. Number of treatment-emergent adverse events per subject		From Day 1 (postdose) up to Day 21
Primary	Part 2. Having clinically significant abnormalities in systolic blood pressure	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 21
Primary	Part 2. Having clinically significant abnormalities in diastolic blood pressure	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 21
Primary	Part 2. Having clinically significant abnormalities in heart rate	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 21
Primary	Part 2. Having clinically significant abnormalities in oral body temperature	Clinical significance (yes/no) of abnormal values as judged by the investigator	From Day 1 (postdose) up to Day 21
Primary	Part 2. Having an abnormal ECG	ECG: electrocardiogram. Abnormal ECG (yes/no) defined as: QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec for males / >470 msec for females, or maximum change from baseline of >30 msec	From Day 1 (postdose) up to Day 21
Secondary	Part 1. AUC0-8	AUC0-8: area under the plasma concentration-time curve from time zero to infinity	Derived from plasma concentration-time profile from 0-48 hours postdose
Secondary	Part 1. Cmax	Cmax: maximum plasma concentration	Derived from plasma concentration-time profile from 0-48 hours postdose
Secondary	Part 2. Accumulation ratio		Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Secondary	Part 2. AUC0-24	AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose	Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14
Secondary	Part 2. Cmax	Cmax: maximum plasma concentration	Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14