A clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of LEO 153339 in healthy subjects
- Conditions
- Psoriasis
- Registration Number
- NL-OMON51974
- Lead Sponsor
- eo Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 134
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of LEO 153339 in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetics (PK) of LEO 153339 and LEO 159074<br /><br>(N-glucuronide metabolite) in healthy subjects.</p><br>