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Study of Danicopan in Participants of Japanese Descent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451434
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Danicopan Phase 1

Detailed Description:

This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent.

On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention.

Safety will be assessed throughout the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three-way crossover
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Danicopan 200 mg Fasted
Fasting participants will receive a single dose of 200 mg danicopan.
Drug: Danicopan
Oral tablet
Other Names:
  • ALXN2040
  • ACH-0144471

Experimental: Danicopan 200 mg Fed
Fed participants will receive a single dose of 200 mg danicopan.
Drug: Danicopan
Oral tablet
Other Names:
  • ALXN2040
  • ACH-0144471

Experimental: Danicopan 400 mg Fed
Fed participants will receive a single dose of 400 mg danicopan.
Drug: Danicopan
Oral tablet
Other Names:
  • ALXN2040
  • ACH-0144471




Primary Outcome Measures :
  1. Number Of Participants With Treatment-Emergent Adverse Events [ Time Frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose) ]
  2. Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ]
  3. Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ]
  4. Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States [ Time Frame: up to 72 hours postdose ]
  5. Dose Proportionality Of Danicopan In Fed State Assessed by AUC [ Time Frame: up to 72 hours postdose ]
  6. Dose Proportionality Of Danicopan In Fed State Assessed by Cmax [ Time Frame: up to 72 hours postdose ]

Secondary Outcome Measures :
  1. Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay [ Time Frame: up to 72 hours postdose ]
    Blood samples will be collected for measurement of danicopan activity.

  2. Complement Factor B Fraction b Levels [ Time Frame: up to 72 hours postdose ]
    Blood samples will be collected for measurement of complement factor B fraction b levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. 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.
  3. 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.

Exclusion Criteria:

  1. Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
  2. 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.
  3. History or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents.
  4. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  5. History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention.
  6. Any major surgery within 4 weeks of the first dose of study intervention.
  7. Diagnosis or history of Gilbert's syndrome, in the opinion of the Investigator or designee.
  8. Unable to refrain from or anticipates the use of any drug.
  9. Receipt of a vaccine within 30 days prior to the first dose of study intervention.
  10. Receipt of blood products within 6 months prior to the first dose of study intervention.
  11. 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.
  12. Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening.
  13. Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus.
  14. Current tobacco users and smokers or a positive cotinine test at screening.
  15. 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.
  16. Positive drugs of abuse screen at screening or Day -1 of Period 1.
  17. Positive results for alcohol screen at screening or Day -1 of Period 1.
  18. Is a female with a positive pregnancy test at screening or Day -1 of Period 1 or who is lactating, or who plan to become pregnant (within 5 months of screening).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451434


Contacts
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Contact: Alexion Pharmaceuticals, Inc 855-752-2356 clinicaltrials@alexion.com

Locations
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Australia
Clinical Study Site
Brisbane, Australia
Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04451434    
Other Study ID Numbers: ALXN2040-HV-101
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals:
Factor D inhibitor
Complement
Danicopan
Pharmacokinetics
Japanese
Food