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

NCT02316912 | Completed Phase 1

• 1 other identifier: ATX2417/001/14
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Keywords

allergy

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events as a measure of safety and tolerability

  Number of subjects with adverse events

  120 hours after dosing

Secondary Outcomes (2)

• AUC0-t

  120 hours after single dose

• AUC0-t

  120 hours after eighth dose

Study Arms (18)

Single dose level 1 active

ACTIVE COMPARATOR

Six subjects ATX2417 I mg tablet once.

Drug: ATX2417

Single dose level 2 active

ACTIVE COMPARATOR

Six subjects ATX2417 2x1 mg tablet once.

Drug: ATX2417

Single dose level 3 active

ACTIVE COMPARATOR

Six subjects ATX2417 5 mg tablet once.

Drug: ATX2417

Single dose level 4 active

ACTIVE COMPARATOR

Six subjects ATX2417 4x5 mg tablets once.

Drug: ATX2417

Single dose level 5 active

ACTIVE COMPARATOR

Six subjects ATX2417 to be determined.

Drug: ATX2417

Multiple dose level 1 active

ACTIVE COMPARATOR

Six subjects ATX2417 dose to be determined once daily for 8 days.

Drug: ATX2417

Multiple dose level 2 active

ACTIVE COMPARATOR

Six subjects ATX2417 dose to be determined once daily for 8 days.

Drug: ATX2417

Single dose level 1 placebo

PLACEBO COMPARATOR

Two subjects one placebo tablet once.

Drug: Placebo

Single dose level 2 placebo

PLACEBO COMPARATOR

Two subjects one placebo tablet x2 once.

Drug: Placebo

Single dose level 3 placebo

PLACEBO COMPARATOR

Two subjects one placebo tablet once.

Drug: Placebo

Single dose level 4 placebo

PLACEBO COMPARATOR

Two subjects two placebo tablets once.

Drug: Placebo

Single dose level 5 placebo

PLACEBO COMPARATOR

Two subjects four placebo tablets once.

Drug: Placebo

Multiple dose level 1 placebo

PLACEBO COMPARATOR

Two subjects matching placebo(s) once daily for 8 days

Drug: Placebo

Multiple dose level 2 placebo

PLACEBO COMPARATOR

Two subjects matching placebo(s) once daily for 8 days.

Drug: Placebo

Single dose level 6 active

ACTIVE COMPARATOR

Six subjects ATX2417 to be determined.

Drug: ATX2417

Single dose level 7 active

ACTIVE COMPARATOR

Six subjects ATX2417 to be determined.

Drug: ATX2417

Single dose level 6 placebo

PLACEBO COMPARATOR

Six subjects placeboto be determined.

Drug: Placebo

Single dose level 7 placebo

PLACEBO COMPARATOR

Six subjects placebo to be determined.

Drug: Placebo

Interventions

ATX2417 DRUG

Randomised double blind parallel group ascending dose assessment

Multiple dose level 1 active; Multiple dose level 2 active; Single dose level 1 active; Single dose level 2 active; Single dose level 3 active; Single dose level 4 active; Single dose level 5 active; Single dose level 6 active; Single dose level 7 active

Placebo DRUG

Randomised double blind parallel group ascending dose assessment

Multiple dose level 1 placebo; Multiple dose level 2 placebo; Single dose level 1 placebo; Single dose level 2 placebo; Single dose level 3 placebo; Single dose level 4 placebo; Single dose level 5 placebo; Single dose level 6 placebo; Single dose level 7 placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects, any racial group
• Able to comply with the protocol
• Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)

You may not qualify if:

• A history of gastrointestinal disorder likely to influence drug absorption
• 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
• Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
• A history of drug or alcohol abuse
• Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)

Sponsors & Collaborators

• Atopix Therapeutics, Ltd.: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research

Merthyr Tydfil, Glamorgan, CF48 4DR, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Khalid Abou Farha, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 15, 2014
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

GB (1)