PK of daily CD5789 in healthy Japanese and non-Japanese subjects
Research type
Research Study
Full title
Pharmacokinetics study of CD5789 200µg/g and 400µg/g cream HE1 in healthy subjects from Japanese and non-Japanese origins, following daily applications on half of the body
IRAS ID
158279
Contact name
Lorch Ulrike
Contact email
Sponsor organisation
Galderma R&D
Eudract number
2014-001386-28
Research summary
We are conducting a clinical research study with a medicinal cream coded as CD5789 which has been shown to be an effective treatment for skin diseases such as acne vulgaris, commonly known as acne. The sponsor of this study (Galderma R&D) also plan to develop CD5789 cream for treatment of Lamellar Ichthyosis (LI) which is a rare and distressing inherited dermatological disease in which the patients have dry rough skin. CD5789 cream was previously tested at doses of 50-100 µg/g in subjects with acne vulgaris and healthy subjects and it was observed that blood levels were very low. In this study, we want to test a new formulation of CD5789 cream (called "cream HE1") at 200µg/g and 400 µg/g, in healthy volunteers, to determine how much is absorbed into the blood. It is then planned to evaluate these 2 doses in patients with LI. We will compare the data from Japanese and non-Japanese adult healthy volunteers; to see if there are any ethnic differences. We will also assess the safety of CD5789 cream HE1 and how well it is tolerated on the skin of volunteers. The information from this study is necessary as it is planned in the future to conduct clinical trials in LI subjects in various countries including Japan.
The CD5789 cream HE1 will be applied once daily for 29 days to approximately half of the body area. Volunteers will have 32 daily out patient visits to our research unit and will be involved in the study for up to 8 weeks including the screening period time for us to determine their eligibility for the study. The main procedures will include standard laboratory safety tests (blood and urine), vital signs, ECGs, physical examinations, skin assessments, blood samples for pharmacokinetic assessments and monitoring of side effects.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1061
Date of REC Opinion
10 Jul 2014
REC opinion
Favourable Opinion