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

NCT03384186 | Completed Phase 1 FDA Drug

• 2 other identifiers: ACH471-0112017-003525-15
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Danicopan; ALXN2040; ACH-0144471; Pharmacokinetics; Modified Release; Factor D Inhibitor; Relative Bioavailability

Outcome Measures

Primary Outcomes (3)

• Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation

  Up to 72 hours postdose

• Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation

  Up to 72 hours postdose

• 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 Outcomes (1)

• Participants Experiencing Treatment-emergent Adverse Events

  Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)

Study Arms (1)

Danicopan Modified Release Prototype Tablets

EXPERIMENTAL

Participants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing.

Drug: Danicopan Modified Release Prototype 1; Drug: Danicopan Modified Release Prototype 2; Drug: Danicopan Modified Release Prototype 3

Interventions

Danicopan Modified Release Prototype 1 DRUG

Danicopan (400 milligrams \[mg\]) oral tablet.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Danicopan Modified Release Prototype Tablets

Danicopan Modified Release Prototype 2 DRUG

Danicopan (400 mg) oral tablet.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Danicopan Modified Release Prototype Tablets

Danicopan Modified Release Prototype 3 DRUG

Danicopan (800 mg) oral tablet.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Danicopan Modified Release Prototype Tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Achillion, a wholly owned subsidiary of Alexion: collaborator

Study Sites (1)

Clinical Trial Site

Ruddington, Nottingham, NG111 6JS, United Kingdom

Location

MeSH Terms

Interventions

danicopan; rhoA GTP-Binding Protein

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 27, 2017
• Study Start: December 1, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)