NCT02140268

To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

Detailed description

A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Midazolam	Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1
DRUG	AZD1722	Volunteers will receive twice daily, oral doses of AZD1722 15 mg on Days 2-14
DRUG	AZD1722 and Midazolam	On Day 15 volunteers will receive AZD1722 15 mg and Midazolam 7.5 mg at the same time in the morning. In the evening on Day 15 AZD1722 15 mg will be administered alone.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-05-16
• Last updated: 2015-09-22

Locations

1 site across 1 country: United States