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

NCT ID: NCT02140268

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Midazolam 7.5 mg

Volunteers will receive Midazolam 7.5 mg administered by mouth as a syrup

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1

AZD1722 15 mg

Volunteers will received AZD1722 15 mg administered by mouth, as a tablet

Group Type: EXPERIMENTAL

AZD1722

Intervention Type: DRUG

Volunteers will receive twice daily, oral doses of AZD1722 15 mg on Days 2-14

AZD1722 15 mg and Midazolam 7.5 mg

Volunteers will receive AZD1722 15 mg tablet and Midazolam 7.5 mg syrup, by mouth

Group Type: EXPERIMENTAL

AZD1722 and Midazolam

Intervention Type: DRUG

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.

Interventions

Midazolam

Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1

Intervention Type: DRUG

AZD1722

Volunteers will receive twice daily, oral doses of AZD1722 15 mg on Days 2-14

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Females of childbearing potential must have a negative pregnancy test at screening, Day -1, and Day 14 and must not be lactating and use effective contraceptive methods to avoid pregnancy during the treatment period

Male healthy volunteers with a partner of childbearing potential must agree to avoid fathering a child, and refrain from donating sperm, from the first day of dosing until at least 3 months after last dose of the investigational product, and therefore be either sterile or agree to use approved methods of contraception

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the principal investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study. History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. Loose stools (BSFS of 6 or 7) ≥2 days in the past 7 days before investigational product administration. Use of medications that are known to affect stool consistency and/or GI motility, including fiber supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements, or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before the investigational product administration. Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of investigational product or longer if the medication has a long half-life. Use of drugs or substances with enzyme-inducing properties within 4 weeks prior to the first administration of investigational product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ardelyx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleanor Lisbon, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

D5613C00003

Identifier Type: -

Identifier Source: org_study_id