A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

Healthy Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384186
• Other study ID #: ACH471-011
• Secondary ID: 2017-003525-15
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2017
• Est. completion date: March 21, 2018

Study information

• Verified date: August 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan Modified Release Prototype 1
Danicopan (400 milligrams [mg]) oral tablet.
• Danicopan Modified Release Prototype 2
Danicopan (400 mg) oral tablet.
• Danicopan Modified Release Prototype 3
Danicopan (800 mg) oral tablet.

Locations

Country	Name	City	State
United Kingdom	Clinical Trial Site	Ruddington	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation		Up to 72 hours postdose
Primary	Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation		Up to 72 hours postdose
Primary	Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation		Up to 72 hours postdose
Secondary	Participants Experiencing Treatment-emergent Adverse Events		Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)