Clinical trial NCT03384186: A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
Official title: A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Danicopan
ALXN2040
ACH-0144471
Pharmacokinetics
Modified Release
Factor D Inhibitor
Relative Bioavailability
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2017-12-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.


Eligibility criteria: Inclusion Criteria:

* Body mass index of 18.0 to 30.0 kilograms/square meter.
* Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
* Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.

Exclusion Criteria:

* Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
* History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
* Clinically significant laboratory abnormalities.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
* History or family history of meningococcal infection.
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
* Presence or history of clinically significant allergy requiring treatment.
* Donation or loss of greater than 400 milliliters of blood within the previous 3 months.

Note: Other inclusion/exclusion criteria may apply, per protocol.

Primary outcomes:
measure: Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation
timeFrame: Up to 72 hours postdose
measure: Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation
timeFrame: Up to 72 hours postdose
measure: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Clinical Trial Site
state: Nottingham
Study officials:
References: