Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants

NCT ID: NCT05202145

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-03-21

Brief Summary

This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).

Conditions

Healthy

Study Design

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

Study Groups

Part 1 - Cyclosporine

Participants will receive ALXN2050 and cyclosporine in a fixed sequence over 3 periods.

Period 1: Participants will receive multiple doses of ALXN2050.

Period 2: Participants will receive multiple doses of cyclosporine.

Period 3: Participants will receive multiple doses of ALXN2050 co-administered with multiple doses of cyclosporine.

There will be a washout period between the last dose of ALXN2050 in Period 1 and the first dose of cyclosporine in Period 2 and between the last dose of cyclosporine in Period 2 and the first dosing in Period 3.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Oral tablet.

Cyclosporine

Intervention Type: DRUG

Oral capsule.

Part 2 - Tacrolimus

Participants will receive tacrolimus and ALXN2050 in a fixed sequence over 2 periods.

Period 1: Participants will receive a single dose of tacrolimus.

Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of tacrolimus.

There will be a washout period between the dose of tacrolimus in Period 1 and the first dose of ALXN2050 in Period 2.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Oral tablet.

Tacrolimus

Intervention Type: DRUG

Oral capsule.

Part 3 - MMF

Participants will receive MMF and ALXN2050 in a fixed sequence over 2 periods.

Period 1: Participants will receive a single dose of MMF.

Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of MMF.

There will be a washout period between the dose of MMF in Period 1 and the first dose of ALXN2050 in Period 2.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Oral tablet.

MMF

Intervention Type: DRUG

Oral tablet.

Interventions

ALXN2050

Oral tablet.

Intervention Type: DRUG

Cyclosporine

Oral capsule.

Intervention Type: DRUG

Tacrolimus

Oral capsule.

Intervention Type: DRUG

MMF

Oral tablet.

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 (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee at Screening.
• Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter^2, 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.
• 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.
• 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 users or smokers 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 Study Site

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ALXN2050-HV-110

Identifier Type: -

Identifier Source: org_study_id