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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995550
Recruitment Status : Withdrawn (Portfolio proritisation)
First Posted : June 24, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: LEO 142397 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: Single ascending dose Cohort A
Single dose of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort B
Single dose of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort C
2 single doses, separated by a washout of ≥7 days.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort D
2 single doses, separated by a washout of ≥7 days.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort E
Single dose of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort F
Single dose of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort G
Single dose of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Single ascending dose Cohort H
Single dose of LEO 142397 or placebo - tentative, female-only cohort (to be included only if the number of women recruited in the remaining cohorts is insufficient to assess the pharmacokinetics of LEO 142397 in women). Dose level ≥ that in Cohort C and ≤ that in Cohort D.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort K
Multiple doses of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort L
Multiple doses of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort M
Multiple doses of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort N
Multiple doses of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort O
Multiple doses of LEO 142397 or placebo.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo

Experimental: Multiple ascending dose Cohort P
Multiple doses of LEO 142397 or placebo in Japanese-only subjects. Same dose level as for Cohort M.
Drug: LEO 142397
A compound in development by LEO Pharma A/S

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Part 1. Number of treatment-emergent adverse events per subject [ Time Frame: From Day 1 (postdose) up to Day 8 ]
  2. Part 1. Having clinically significant abnormalities in systolic blood pressure [ Time Frame: From Day 1 (postdose) up to Day 8 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  3. Part 1. Having clinically significant abnormalities in diastolic blood pressure [ Time Frame: From Day 1 (postdose) up to Day 8 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  4. Part 1. Having clinically significant abnormalities in heart rate [ Time Frame: From Day 1 (postdose) up to Day 8 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  5. Part 1. Having clinically significant abnormalities in oral body temperature [ Time Frame: From Day 1 (postdose) up to Day 8 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  6. Part 1. Having an abnormal ECG [ Time Frame: From Day 1 (postdose) up to Day 8 ]
    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

  7. Part 2. Number of treatment-emergent adverse events per subject [ Time Frame: From Day 1 (postdose) up to Day 21 ]
  8. Part 2. Having clinically significant abnormalities in systolic blood pressure [ Time Frame: From Day 1 (postdose) up to Day 21 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  9. Part 2. Having clinically significant abnormalities in diastolic blood pressure [ Time Frame: From Day 1 (postdose) up to Day 21 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  10. Part 2. Having clinically significant abnormalities in heart rate [ Time Frame: From Day 1 (postdose) up to Day 21 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  11. Part 2. Having clinically significant abnormalities in oral body temperature [ Time Frame: From Day 1 (postdose) up to Day 21 ]
    Clinical significance (yes/no) of abnormal values as judged by the investigator

  12. Part 2. Having an abnormal ECG [ Time Frame: From Day 1 (postdose) up to Day 21 ]
    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


Secondary Outcome Measures :
  1. Part 1. AUC0-∞ [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    AUC0-∞: area under the plasma concentration-time curve from time zero to infinity

  2. Part 1. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-48 hours postdose ]
    Cmax: maximum plasma concentration

  3. Part 2. Accumulation ratio [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
  4. Part 2. AUC0-24 [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
    AUC0-24: area under the plasma concentration-time curve from time zero to 24 hours postdose

  5. Part 2. Cmax [ Time Frame: Derived from plasma concentration-time profile from 0-24 hours postdose on Day 1 and Day 14 ]
    Cmax: maximum plasma concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995550


Locations
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United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03995550    
Other Study ID Numbers: LP0184-1415
2018-004470-10 ( EudraCT Number )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Access Criteria: External researchers with no commercial interest who provide scientifically sound research proposal
URL: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No