NCT01853852View on ClinicalTrials.gov

A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Fabry Disease
Interventions
DRUG

GR181413A/AT1001 solution

Powder for reconstitution

DRUG

GR181413A/AT1001 capsule

Size 2, hard gelatin capsule, white opaque / blue opaque

OTHER

Potable water

Matched, Size 2, hard gelatin capsule, white opaque/blue opaque

DRUG

Placebo capsule

Solution matched

Trial Locations (1)

2031

GSK Investigational Site, Randwick

Sponsors
All Listed Sponsors
lead

Amicus Therapeutics

INDUSTRY

NCT01853852 - A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects | Biotech Hunter | Biotech Hunter