NCT03897413

Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers

An Open-label, Randomized, Three-period, Crossover Study to Assess the Effect of Food and Calcium on S-888711 0.25-mg Tablet Pharmacokinetics in Healthy, Adult Volunteer Subjects Following a Single 0.75-mg Oral Dose of S-888711

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study were: * To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults * To assess the effect of a calcium supplement on the PK of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	S-888711	Administered orally as three 0.25 mg tablets
DIETARY_SUPPLEMENT	Calcium Antacid	Calcium carbonate 4000 mg chewable tablets

Timeline

• Start date: 2009-11-06
• Primary completion: 2009-12-23
• Completion: 2009-12-23
• First posted: 2019-04-01
• Last updated: 2019-04-01

Locations

1 site across 1 country: United States