Study of Multiple Doses 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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-21

Study Completion Date

2017-01-11

Brief Summary

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This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams \[mg\], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted 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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Cohort 1: 200 mg

All participants under fasted conditions received 200 mg of danicopan or placebo twice daily (BID) over a 14-day period.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2: 500 mg

All participants under fasted conditions received 500 mg of danicopan or placebo BID over a 14-day period.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 3: 800 mg

All participants under fasted conditions received 800 mg of danicopan or placebo BID over a 14-day period.

Group Type EXPERIMENTAL

Danicopan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 4: 75 mg

All participants under fasted conditions received 75 mg of danicopan or placebo thrice daily (TID) over a 7-day period.

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 was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart 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 (including gastrectomy and cholecystectomy).
* Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.
* Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have 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

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes