A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628
ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPraxis Precision Medicines
About this trial
A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation
Eligibility criteria
Qualifiers
Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2
Is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
All females have a negative pregnancy test and are not planning to get pregnant for the duration of the trial
Female of non-childbearing potential by reason of surgery or at least 1 year post menopause
Disqualifiers
Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination
History of inflammatory bowel syndrome, gastritis, gastrointestinal or rectal bleeding
History of major gastrointestinal tract surgery (ie, gastrectomy, bowel resection, cholecystectomy etc.)
History or evidence of pancreatic injury or pancreatitis
Trial design
Treatments tested in this trial
- PRAX-628
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov