- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316912
First in Man Evaluation of Single and Multiple Doses of Oral ATX2417
Double Blind Randomised Placebo Controlled Evaluation of Single and Multiple Oral Doses of ATX2417 in Man and Effect of Food
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Glamorgan
-
Merthyr Tydfil, Glamorgan, United Kingdom, CF48 4DR
- Simbec Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single dose level 1 active
Six subjects ATX2417 I mg tablet once.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 2 active
Six subjects ATX2417 2x1 mg tablet once.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 3 active
Six subjects ATX2417 5 mg tablet once.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 4 active
Six subjects ATX2417 4x5 mg tablets once.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 5 active
Six subjects ATX2417 to be determined.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Multiple dose level 1 active
Six subjects ATX2417 dose to be determined once daily for 8 days.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Multiple dose level 2 active
Six subjects ATX2417 dose to be determined once daily for 8 days.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 1 placebo
Two subjects one placebo tablet once.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 2 placebo
Two subjects one placebo tablet x2 once.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 3 placebo
Two subjects one placebo tablet once.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 4 placebo
Two subjects two placebo tablets once.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 5 placebo
Two subjects four placebo tablets once.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Multiple dose level 1 placebo
Two subjects matching placebo(s) once daily for 8 days
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Multiple dose level 2 placebo
Two subjects matching placebo(s) once daily for 8 days.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 6 active
Six subjects ATX2417 to be determined.
|
Randomised double blind parallel group ascending dose assessment
|
Active Comparator: Single dose level 7 active
Six subjects ATX2417 to be determined.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 6 placebo
Six subjects placeboto be determined.
|
Randomised double blind parallel group ascending dose assessment
|
Placebo Comparator: Single dose level 7 placebo
Six subjects placebo to be determined.
|
Randomised double blind parallel group ascending dose assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame: 120 hours after dosing
|
Number of subjects with adverse events
|
120 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t
Time Frame: 120 hours after single dose
|
Area under concentration time curve at 120 hours
|
120 hours after single dose
|
AUC0-t
Time Frame: 120 hours after eighth dose
|
Area under concentration time curve at 120 hours
|
120 hours after eighth dose
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Khalid Abou Farha, MD, Simbec Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATX2417/001/14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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