Status and phase
Conditions
Treatments
About
This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
Full description
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
Serious risk of suicide in the opinion of the investigator.
History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
Any condition that could possibly affect drug absorption.
Receipt of SARS-CoV2 vaccine or booster as follows:
Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
Abnormal clinical laboratory test results or vital measurements at Screening.
Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
Primary purpose
Allocation
Interventional model
Masking
12 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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