Psoriasis Psoriasis
Conditions
Interventions
Part 1
The study compound will be given once on Day 1.
The table below shows the planned dose levels for each group. The doses of
later groups can be adjusted. For example because the study compound
Sponsors
Leo Pharma A/S
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy adult males and females. Age between 18 and 65 years (both inclusive) at screening. A body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive). In good health at screening and/or check-in (Day -2 and Day -1) as judged by the investigator based on medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory evaluations.
Exclusion criteria
Exclusion criteria: Male subjects sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (e.g. condom) from the time of first dose of IMP until 3 months after the last dose, in conjunction with this female partner using a highly effective form of contraception. For vasectomised male subjects, male subjects with a female partner with bilateral tubal occlusion or ligation, and heterosexually abstinent male subjects (when this is in line with the preferred and usual life style of the subject and not just being without a current partner), no additional contraception is required. Female subjects who are pregnant, lactating, or of childbearing potential Any surgical or medical condition or cholecystectomy which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. Positive polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at Day -2 or Day -1 or within 8 weeks prior to screening or check-in, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose. Treatment with any prescribed or non-prescribed systemic or topical medication within 7 days prior to the first dose of IMP (excluding paracetamol; including herbal remedies), unless, in the opinion of the investigator and the sponsor, the medication will not interfere with the trial procedures or compromise safety. Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 3 months prior to the first dose of IMP. ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec confirmed by repeat measurement at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of LEO 153339 in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of LEO 153339 and LEO 159074 (N-glucuronide metabolite) in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed