Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.
This randomized, open-label, 2-period, 2-sequence, crossover study is designed to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28, which is being developed for the treatment of lactose intolerance. The study consists of a screening visit (during the interval from Day -21 to Day -3), baseline/check-in to the clinical research unit (Day -2 to Day -1), 2 treatment periods (Day 1 and Day 3), a 48-hour washout between doses, check-out from the clinical research unit (Day 4), and 1 follow-up phone call conducted 7 to 10 days after the final dose of the study drug (i.e., during the interval from Day 10 to Day 13). The duration of subject study participation is approximately 5 weeks. Plasma samples for PK analysis will be taken at specified timepoints from 24 hours prior to each dose through 24 hours after each dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
RP-G28 is a purified galacto-oligosaccharide (GOS) product
Syneos Health
Miami, Florida, United States
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Assess systemic exposure of RP-G28 when administered in the fed and fasted state
Time frame: Days 2 and 1 pretreatment; Day 1 post-treatment, Day 1-3 washout, Day 3 and 4 post-treatment
Adverse events
Adverse events will be continuously monitored throughout the entire study, including follow-up.
Time frame: 2, 3, 2 and 1 days pretreatment; 1 - 13 days post-treatment
Serum chemistry
Albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, carbon dioxide, creatinine, total bilirubin, gamma glutamyl transferase, glucose, lactic dehydrogenase (lactate dehydrogenase), phosphorus, potassium, sodium, total cholesterol, total protein, uric acid, and vitamin D.
Time frame: 21 and 3 days pretreatment; day 4 post-treatment
Hematology
Number of subjects with abnormal laboratory values will be flagged and summarized separately
Time frame: 21 and 3 days pretreatment; day 4 post-treatment
Urinalysis
Number of subjects with abnormal laboratory values will be flagged and summarized separately
Time frame: 2, 3, 2 and 1 days pretreatment; day 1 and 3 post-treatment
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