A randomised, open-label, two-way crossover study comparing the pharmacokineticsof a solid dosage form and a solution of PN-943 in healthy volunteers
- Conditions
- lcerative ColitisUlcerative ColitisOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12619001444178
- Lead Sponsor
- Protagonist Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Normal healthy volunteers 18-55 years
Good general health,
BMI 18-30kg/m2
Non-smokers
Lab values within normal range. Willing to consume standard meal provided (Standard meal will be as advised by the clinic and principal investigator).
Ability and willingness to attend visits to the site and provide written informed consent prior to entry into the study.
History of significant abnormalities or diseases
Clinical significant lab or ECG abnormalities
History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular,
haematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
History of neoplastic disease
Mentally or legally incapacitated
History of severe allergic or anaphylactic reactions
History of substance abuse, severe allergic or anaphylactic reactions. Regular Alcohol consumption (>21units per week).
Clinically significant lab abnormality or ECG
Inability to comply with the requirements of the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method