Study of a Single Dose of Danicopan 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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-04

Study Completion Date

2016-06-21

Brief Summary

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This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: 200 mg

All participants (fasted) received either 200 mg of danicopan as a single oral dose or dose-matched placebo.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Group 2: 600 mg

All participants (fasted) received either 600 mg of danicopan as a single oral dose or dose-matched placebo.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Group 3: 1200 mg

All participants (fasted) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Group 4: 2400 mg

All participants (fasted) received either 2400 mg of danicopan administered as 2 single doses of 1200 mg each, 12 hours apart, or dose-matched placebo.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Group 5: 1200 mg

All participants (fed) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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ACH-0144471 (formerly) ALXN2040 ACH-4471 ACH4471 4471

Eligibility Criteria

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Inclusion Criteria

* Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.

Exclusion Criteria

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Any condition possibly affecting drug absorption (for example, gastrectomy), cholecystectomy to be considered acceptable.
* Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
* Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of Screening; positive urine drug screen at Screening or Day -1.
* Clinically significant laboratory abnormalities at either Screening or Day -1.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes