Study of Danicopan in Participants of Japanese Descent

NCT04451434 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ALXN2040-HV-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.

Conditions

Healthy

Keywords

Factor D inhibitor; Complement; Danicopan; Pharmacokinetics; Japanese; Food

Outcome Measures

Primary Outcomes (6)

• Number Of Participants With Treatment-Emergent Adverse Events

  Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)

• Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States

  up to 72 hours postdose

• Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States

  up to 72 hours postdose

• Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States

  up to 72 hours postdose

• Dose Proportionality Of Danicopan In Fed State Assessed by AUC

  up to 72 hours postdose

• Dose Proportionality Of Danicopan In Fed State Assessed by Cmax

  up to 72 hours postdose

Secondary Outcomes (2)

• Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay

  up to 72 hours postdose

• Complement Factor B Fraction b Levels

  up to 72 hours postdose

Study Arms (3)

Danicopan 200 mg Fasted

EXPERIMENTAL

Fasting participants will receive a single dose of 200 mg danicopan.

Drug: Danicopan

Danicopan 200 mg Fed

EXPERIMENTAL

Fed participants will receive a single dose of 200 mg danicopan.

Drug: Danicopan

Danicopan 400 mg Fed

EXPERIMENTAL

Fed participants will receive a single dose of 400 mg danicopan.

Drug: Danicopan

Interventions

Danicopan DRUG

Oral tablet

Also known as: ALXN2040, ACH-0144471

Danicopan 200 mg Fasted; Danicopan 200 mg Fed; Danicopan 400 mg Fed

Eligibility Criteria

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

You may qualify if:

• Participants who are of Japanese descent defined as:
• First generation (born to 2 Japanese parents and 4 Japanese grandparents)
• Born in Japan, and not have lived outside Japan for greater than 10 years
• Lifestyle, including diet, must not have significantly changed since leaving Japan
• No clinically significant history or presence of electrocardiogram findings as judged by the Investigator at screening and prior to the first dose of study intervention in Period 1.
• Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meters squared, inclusive, with a minimum body weight of 50.0 kg at screening.

You may not qualify if:

• Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
• History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
• History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents.
• History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
• History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention.
• Any major surgery within 4 weeks of the first dose of study intervention.
• Diagnosis or history of Gilbert's syndrome, in the opinion of the Investigator or designee.
• Unable to refrain from or anticipates the use of any drug.
• Receipt of a vaccine within 30 days prior to the first dose of study intervention.
• Receipt of blood products within 6 months prior to the first dose of study intervention.
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
• Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening.
• Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus.
• Current tobacco users and smokers or a positive cotinine test at screening.
• Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Study Site

Brisbane, Australia

Location

MeSH Terms

Interventions

danicopan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-way crossover

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 30, 2020
• Study Start: August 17, 2020
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)