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

Phase 1

Completed

• Conditions: Allergy
• Interventions: Drug: ATX2417; Drug: Placebo

• Registration Number: NCT02316912
• Lead Sponsor: Atopix Therapeutics, Ltd.

Brief 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.

Detailed Description

The study consists of two parts, A (single ascending dose including fasted/fed comparison) and B (multiple ascending dose). Part B will be conducted after a thorough review by the Sponsor and the Principal Investigator of the data arising from part A.

Part A This will be a randomised, double blind, placebo controlled, parallel group titration of up to seven single dose levels of ATX2417. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. At each dose level, 2 subjects (1 subject will receive ATX2417 and 1 subject will receive placebo) will be dosed on Day 1 and the remaining 6 subjects will be dosed at least 24 hours later. Safety and pharmacokinetic observations will be made. There will be a minimum of two weeks between the first dosing day at each dose level. Safety and ATX2417 pharmacokinetic data will be reviewed prior to each dose escalation and, based on pharmacokinetic data, it is also possible to decrease the dose if the pharmacokinetic profile so indicates. This part will also include an assessment of the effect of a high fat breakfast on the absorption and pharmacokinetic profile of ATX 2417, performed at a dose predicted to be associated with therapeutic plasma concentrations.

Part B Following completion of Part A, and selection of appropriate dose levels, Part B will be performed. This will be a randomised, double blind, placebo controlled, parallel group study of up to two dose levels of ATX2417 given once daily for eight days. In each cohort, six subjects will receive active compound and two will receive placebo in a randomised fashion. Safety and pharmacokinetic observations will be made.

Study Timeline

• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-15
• Study Start: 2015-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose level 5 active	ATX2417	Six subjects ATX2417 to be determined.
Multiple dose level 2 placebo	Placebo	Two subjects matching placebo(s) once daily for 8 days.
Single dose level 7 placebo	Placebo	Six subjects placebo to be determined.
Single dose level 2 active	ATX2417	Six subjects ATX2417 2x1 mg tablet once.
Single dose level 4 placebo	Placebo	Two subjects two placebo tablets once.
Single dose level 5 placebo	Placebo	Two subjects four placebo tablets once.
Single dose level 6 placebo	Placebo	Six subjects placeboto be determined.
Single dose level 2 placebo	Placebo	Two subjects one placebo tablet x2 once.
Multiple dose level 1 placebo	Placebo	Two subjects matching placebo(s) once daily for 8 days
Single dose level 4 active	ATX2417	Six subjects ATX2417 4x5 mg tablets once.
Single dose level 1 placebo	Placebo	Two subjects one placebo tablet once.
Single dose level 3 placebo	Placebo	Two subjects one placebo tablet once.
Multiple dose level 1 active	ATX2417	Six subjects ATX2417 dose to be determined once daily for 8 days.
Single dose level 7 active	ATX2417	Six subjects ATX2417 to be determined.
Single dose level 1 active	ATX2417	Six subjects ATX2417 I mg tablet once.
Single dose level 3 active	ATX2417	Six subjects ATX2417 5 mg tablet once.
Single dose level 6 active	ATX2417	Six subjects ATX2417 to be determined.
Multiple dose level 2 active	ATX2417	Six subjects ATX2417 dose to be determined once daily for 8 days.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events as a measure of safety and tolerability	120 hours after dosing	Number of subjects with adverse events

Secondary Outcome Measures

Name	Time	Method
AUC0-t	120 hours after eighth dose	Area under concentration time curve at 120 hours

Trial Locations

Locations (1)

Simbec Research; 🇬🇧 Merthyr Tydfil, Glamorgan, United Kingdom