A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2017-06-16

Brief Summary

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The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Part 1, Part 2, and Part 3 could be conducted concurrently or separately, and the order of the parts could be determined according to the needs of the program.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1: Danicopan and Midazolam

Period 1: Participants received a single dose of midazolam.

Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam.

Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Oral tablet.

Midazolam

Intervention Type DRUG

Oral syrup.

Part 2: Danicopan and Fexofenadine

Period 1: Participants received a single dose of fexofenadine.

Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine.

Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Oral tablet.

Fexofenadine

Intervention Type DRUG

Oral tablet.

Part 3: Danicopan and MMF

Period 1: Participants received a single dose of MMF.

Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF.

Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Oral tablet.

Mycophenolate Mofetil

Intervention Type DRUG

Oral tablet.

Interventions

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Danicopan

Oral tablet.

Intervention Type DRUG

Midazolam

Oral syrup.

Intervention Type DRUG

Fexofenadine

Oral tablet.

Intervention Type DRUG

Mycophenolate Mofetil

Oral tablet.

Intervention Type DRUG

Other Intervention Names

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ALXN2040 ACH-0144471 (formerly) Midazolam HCl

Eligibility Criteria

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Inclusion Criteria

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.

Exclusion Criteria

* Mentally or legally incapacitated or significant emotional problems.
* Any condition that might interfere with drug absorption.
* History of sensitivity to study medication or other drug allergies.
* Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
* Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
* Participated in another clinical study within 28 days prior to the first dose.
* Significant laboratory abnormalities.
* Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes