Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01425450|
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : October 31, 2011
The study aims to:
- study the safety of the drug (HF1020) in healthy male adults
- study how well the study drug (HF1020) is tolerated in healthy male adults
- find the maximum dose that is tolerated in healthy male adults
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer Study||Drug: HF1020 Drug: HF1020 placebo||Phase 1|
This is a single-centre, randomised, double-blind, placebo-controlled, ascending dose study.
Male subjects will be randomised to give a total of 32 evaluable subjects.
Subjects will be sequentially enrolled into 4 cohorts of ascending dose.
Subjects in Cohort 1 will be randomised to receive 0.5 milligrams (mg) HF1020 or placebo (ratio 3:1). When at least 8 subjects within the cohort have completed Day 2 procedures (i.e. Day 1 + 24 hours) and all ongoing subjects have completed the final Day 15 visit, a Safety Review Committee (SRC) will meet, review all safety data prior to dose escalation to the next cohort.
Subjects in Cohort 2 will be randomised to receive 2.5 mg HF1020 or placebo.
Subjects in Cohort 3 will be randomised to receive 10mg HF1020 or placebo.
Subjects in Cohort 4 will be randomised to receive 25mg HF1020 or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised, Double-blind Placebo-controlled Study to Assess the Safety of Four Single Ascending Doses of HF1020 in Healthy Male Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Single doses at 0.5 mg capsules, 2.5 mg capsules, 10 mg capsules, and 25 mg capsules in each of cohorts 1, 2, 3 and 4 respectively.
|Placebo Comparator: Placebo||
Drug: HF1020 placebo
Single dose: HF1020 placebo capsule
- Adverse Events [ Time Frame: Up to day 15 ]All Adverse events occuring from consent until subject completion will be reviewed at each clinic visit. Subjects will be questioned regarding any events that may have occured between clinic vists.
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): NCT01425450
|Medicines Evaluation Unit|
|Manchester, Lancashire, United Kingdom, M23 9QZ|