Phase I study to investigate safety, tolerability and PK of ACT-280778
Research type
Research Study
Full title
A Phase 1, double-blind, placebo-controlled, randomised, multiple ascending oral dose study to investigate the safety, tolerability and pharmacokinetics of ACT-280778 in healthy male subjects.
IRAS ID
52558
Contact name
J. Brian Sanderson
Contact email
Sponsor organisation
Actelion Pharmaceuticals Limited
Eudract number
2010-019534-27
Research summary
The principle aim of this study is to obtain information regarding the safety, tolerability, and the bodily absorption and distribution of the drug, ACT-280778 when given to healthy male subjects. ACT-280778 will be given by mouth, once per day for 7 days. 20 healthy male subjects will be studied in 2 groups, each group consisting of 10 subjects, each subject participating in one treatment period. The health of subjects will be determined by thorough medical checks (physical examination, blood and urine tests, vital signs and heart tracings (ECGs)at study start and end. There will be intensive safety monitoring before, during and after the days on which study drug is given. 7 of the first group of subjects will receive a 5mg dose of the study drug and 3 will receive placebo. If this dose is determined be safe based on a thorough review of all available safety, tolerability and PK information dosing of the second group with a 15 mg dose will commence. The two doses planned for administration in this study have previously been given as single doses in the AC-067-101 study with no clinically relevant abnormalities noted. Before the start of the study, a formal risk assessment will be carried out and documented by the site to ensure that all potential risks are considered, identified and addressed. The maximum duration of the study for each subject will be approximately 8 weeks. The screening period will occur 3 to 21 days prior to drug administration. Each subject will reside at the unit from Day -2 (2 days before dosing) to Day 10 (72 hrs post last dose of study drug). Follow-up will be via telephone 30 days after last dose.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
10/S1402/31
Date of REC Opinion
27 May 2010
REC opinion
Favourable Opinion