Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143

• Status: Completed
• Trial end date: 2017-02-24
• Target enrollment: 0
• Participant gender: Male

Summary

This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required.

In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).

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

Details

• Lead Sponsor: MEI Pharma, Inc.
• Collaborator: Quotient Clinical

Criteria

Inclusion Criteria:

1. Healthy males

2. Age 18 to 65 years of age

3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator

4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast

5. Must be willing and able to communicate and participate in the whole study

6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care

7. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Healthy males

2. Age 18 to 65 years of age

3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator

4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast

5. Must be willing and able to communicate and participate in the whole study

6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care

7. Must agree to use an adequate method of contraception