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Completed

NCT Number: NCT04609696

Study of the Metabolism of Danicopan in Healthy Adults

This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

About this study

For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
  • Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
  • Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
  • Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion criteria

  • History of any medical or psychiatric condition or disease that 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 drug or alcohol abuse within previous 2 years, current tobacco user, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period 1.
  • History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  • History of procedures that could alter absorption or excretion of orally administered drugs.
  • History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
  • Body temperature ≥ 38.0°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
  • 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 before first dosing, whichever is longer.
  • Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, receipt of blood products within 6 months prior to first dosing, or receipt of a vaccine within 30 days prior to first dosing.
  • Is a female with a positive pregnancy test or who is lactating.

Treatment and study plan

Danicopan: Powder-In-Capsule 1

Drug

Danicopan (200 milligrams) will be administered orally on Day 1.

Other names: ALXN2040, ACH-0144471 (formerly)

Danicopan: Powder-In-Capsule 2

Drug

Danicopan (200 milligrams) will be administered orally on Day 1.

Other names: ALXN2040, ACH-0144471 (formerly)

Danicopan: Tablet

Drug

Danicopan (200 milligrams) will be administered orally on Day 1.

Other names: ALXN2040, ACH-0144471 (formerly)

Primary outcomes

  1. Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation

    Time frame: Up to 72 hours postdose

    The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).

  2. AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  3. AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  4. Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  5. Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  6. Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation

    Time frame: Up to 72 hours postdose

    The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.

  7. AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  8. AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  9. Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  10. Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

Secondary outcomes

  1. Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions

    Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)

  2. Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions

    Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)

  3. Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions

    Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)

  4. Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions

    Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study title

A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2020
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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