Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants

NCT ID: NCT04933682

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2021-08-04

Brief Summary

This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in healthy adult participants. Part 1 will be a 2-period, fixed-sequence study. Part 2 will be a single-period, fixed-sequence study.

Conditions

Healthy

Study Design

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

Study Groups

Part 1: ALXN2050 plus Fluconazole

Period 1: Participants will receive a single dose of ALXN2050 alone and in the presence of multiple doses of fluconazole.

Period 2: Participants will receive multiple doses of ALXN2050 alone and in the presence of multiple doses of fluconazole.

Scheduled pharmacokinetics (PK) blood samples for both ALXN2050 and fluconazole will be collected, with a washout period of at least 14 days between the last dose of fluconazole in Period 1 and the first dose of ALXN2050 in Period 2.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Oral tablet.

Fluconazole

Intervention Type: DRUG

Oral tablet.

Part 2: ALXN2050 plus Rifampin

Participants will receive a single dose of ALXN2050 alone and in the presence of both single and multiple doses of rifampin.

Scheduled PK blood samples for both ALXN2050 and rifampin will be collected.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Oral tablet.

Rifampin

Intervention Type: DRUG

Oral capsule.

Interventions

ALXN2050

Oral tablet.

Intervention Type: DRUG

Fluconazole

Oral tablet.

Intervention Type: DRUG

Rifampin

Oral capsule.

Intervention Type: DRUG

Other Intervention Names

ACH-0145228 (formerly)

Eligibility Criteria

Inclusion Criteria

• Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
• Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

Exclusion Criteria

• History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
• History of significant multiple and/or severe allergies.
• Any previous procedure that could alter absorption or excretion of orally administered drugs.
• Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
• Body temperature ≥ 38.0°Celsius, at Screening or prior to the first dose of study intervention.
• History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine user or smoker or a positive cotinine test at Screening.
• Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ALXN2050-HV-105

Identifier Type: -

Identifier Source: org_study_id