NCT03563846

Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects

Prospective, Open-Label, Randomized, Two-Period, Two-Sequence, Crossover Study Comparing RP-G28 Administered in the Fasted State and the Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Ritter Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
DRUG	RP-G28	RP-G28 is a purified galacto-oligosaccharide (GOS) product

Timeline

• Start date: 2018-03-09
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2018-06-20
• Last updated: 2018-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study