First in Man Evaluation of Single and Multiple Doses of Oral ATX2417

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atopix Therapeutics, Ltd.
• Collaborator: Simbec Research

Criteria

Inclusion Criteria:

1. Healthy male subjects, any racial group

2. Able to comply with the protocol

3. Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)

Exclusion Criteria:

1. A history of gastrointestinal disorder likely to influence drug absorption

2. Receipt of any medication including over the counter preparations and vitamins within 14 days of the first dose of study drug with the exception of paracetamol up to a maximum of 2 g daily

3. Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction

4. A history of drug or alcohol abuse

5. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)