Clinical Research Directory

A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS

Sponsor: Galimedix Therapeutics Inc

Summary

This first-in-human Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of GAL-101 salt following oral administration to healthy adult and elderly participants. A total of 92 participants were enrolled at a single study center. The study consisted of five parts. Part 1 evaluated single ascending doses of enteric-coated GAL-101 capsules compared with placebo in healthy adults. Part 2 compared a single dose of enteric-coated GAL-101 capsules with uncoated GAL-101 salt mixed with apple sauce in an open-label crossover design. Part 3 evaluated the effect of fasting, a standard meal, and a high-fat, high-calorie meal on the pharmacokinetics of a single dose of uncoated GAL-101 salt in an open-label crossover design. Part 4 evaluated multiple ascending doses of uncoated GAL-101 salt administered once daily for 7 days compared with placebo. Part 5 evaluated the pharmacokinetics of a single dose of uncoated GAL-101 salt compared with placebo in healthy elderly participants aged 65 to 85 years.

Official title: A SINGLE CENTER, 5-PART, RANDOMIZED, DOUBLE-BLIND AND PLACEBO-CONTROLLED (Parts 1, 4, 5), OPEN-LABEL AND CROSSOVER (Parts 2, 3) STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES (Parts 1, 4), AND SINGLE DOSES (Parts 2, 3, 5), OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS

Key Details

Conditions

Interventions

Locations (1)