None listed
Conditions
Brief summary
Protagonist Therapeutics, Inc. is developing PN-943 as a potential oral therapy for patients with ulcerative colitis (UC). This study will be conducted in 10 normal healthy volunteers who meet all of the inclusion criteria and none of the exclusion criteria. The study is to assess the multiple dose pharmacokinetics (PK) and pharmacodynamics (PD) of an oral immediate release (IR) tablet of PN-943 compared with an oral solution in healthy volunteers.
Interventions
Intervention: PN-943
Cross over between oral liquid formulation and tablets
Dose 450mg
Subjects will receive the following 2 treatments:
• Treatment A: 450 mg PN-943 twice daily (BID) for 5 days as one 300 mg and one 150 mg
dosage strength IR tablet administered every 12 hours
• Treatment B: 450 mg PN-943 BID for 5 days as an oral solution administered every 12 hours
Ten subjects will be randomised to receive either Treatment A followed by Treatment B, or Treatment B followed by Treatment A. T
Intervention: PN-943 Cross over between oral liquid formulation and tablets Dose 450mg Subjects will receive the following 2 treatments: • Treatment A: 450 mg PN-943 twice daily (BID) for 5 days as one 300 mg and one 150 mg dosage strength IR tablet administered every 12 hours • Treatment B: 450 mg PN-943 BID for 5 days as an oral solution administered every 12 hours Ten subjects will be randomised to receive either Treatment A followed by Treatment B, or Treatment B followed by Treatment A. There will be a minimum washout period of 7 days between treatments. During the treatment period, the participants will receive standard meals as advised by the clinic and the principal investigator (Examples: Pea and Mint Risotto, Yoghurt, Fruit, Pad Thai, chicken/Tofu, Apricot Bites, Roast Pumpkin Spinach Wrap, Veg Bruger on Roast Beef/Roast Vegetables, Gozleme, Buddha bowl, Potato Salad, Couscous Salad). Participants will be in the clinic and intervention will be monitored directly by the study staff.
Sponsors
Protagonist Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Outcome results
None listed