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CompletedNCT04709094Updated Jan 14, 2021

A Drug Interaction Study of Danicopan

A Phase 1 interventional study of Danicopan and Warfarin in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Oct 2019, 6 years 11 months ago, and no results have been posted to the registry.
  • Registered 1 year 5 months after the study started (first participant enrolled Jul 2019, registered Jan 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.

Read the detailed description

This study was conducted to assess the 2-way interaction between danicopan and warfarin (Part 1), bupropion (Part 2), and ethinyl estradiol/norethindrone (EE/NET) as an oral contraceptive (Part 3).

02

Conditions studied

  • Healthy

Keywords

  • Factor D Inhibitor
  • Complement
  • Danicopan
  • Oral Contraceptive
  • Pharmacokinetics
  • Pharmacodynamics
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Parts 1 and 2: adult males or females between 18 and 55 years of age, inclusive, at screening. Part 3: adult females between 18 and 65 years of age, inclusive, at screening.
  2. 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.
  3. No clinically significant history or presence of electrocardiogram abnormalities at screening.
  4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
  5. Female participants must be of non-childbearing potential and need not employ a method of contraception.
  6. Part 1 only: Participant has a negative fecal occult blood test at screening.

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant laboratory abnormalities.
  2. 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.
  3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco/nicotine user, or positive for alcohol and/or drug screen at screening or Day -1 of Period 1.
  4. History or presence of clinically significant seizures, head injury, or head trauma.
  5. History of procedures that could alter absorption or excretion of orally administered drugs.
  6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  7. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
  8. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.
  9. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.

  10. 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.

    Part 1 Only:

  11. History or presence of any of the following, with clinical significance:

    • bleeding disorder(s), including relevant familial history;
    • anemia (for example, history of temporary anemia during pregnancy is acceptable);
    • thromboembolic disease;
    • bleeding in the gastrointestinal tract or central nervous system.
  12. Has active severe gingivitis.
  13. Clinically significant illness, clinically significant surgery, including tooth extraction, trauma, or head injury, within 28 days before Day 1 of Period 1.
  14. Participant is employed or actively involved in any circumstance that would place them at increased risk of hemorrhage during the study (for example, contact sports, strenuous or unaccustomed weight lifting, running, bicycling).

  15. Participant has taken large daily doses of vitamin K (> 25 micrograms/daily) and/or has a diet rich in vitamin K 14 days prior to the first dosing.

    Part 2 Only:

  16. Any significant finding on the Columbia-suicide severity rating scale.

  17. History or presence of any of the following, with clinical significance:

    • bulimia or anorexia nervosa;
    • hypertension;
    • angle-closure glaucoma;
    • seizure disorder;
    • prior seizure to previous bupropion administration;
    • head trauma.

    Part 3 Only:

  18. History or presence of:

    • migraines or severe headaches;
    • thrombotic disorders (thrombophlebitis, deep vein thrombosis);
    • cerebrovascular accident;
    • hypertension;
    • transient ischemic attacks;
    • undiagnosed vaginal bleeding;
    • liver tumors or liver disease;
    • jaundice with previous use of oral contraceptives or past pregnancy;
    • diabetes (including gestational diabetes);
    • carcinoma of the endometrium, breast or other known or suspected estrogen dependent neoplasia;
    • family history of first degree relative with breast, ovarian, cervical, or endometrial/uterine cancer;
    • history of abnormal pap smear (high-grade squamous intraepithelial lesion or greater result) including positive human papilloma virus test and/or cervical cancer, or history of cervical procedures including loop electrosurgical excision procedure or conization;
    • any condition that would contraindicate the use of oral contraceptives.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Part 1: Danicopan and Warfarin

    Period 1: Participants received a single dose of warfarin. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of warfarin. Scheduled pharmacokinetics (PK) and pharmacodynamics samples were collected, with a washout period of at least 14 days between the dose of warfarin in Period 1 and the first dose of danicopan in Period 2.

    Drug: Danicopan · Drug: Warfarin

  • Experimental
    Part 2: Danicopan and Bupropion

    Period 1: Participants received a single dose of bupropion. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of bupropion. Scheduled PK samples were collected, with a washout period of at least 7 days between the dose of bupropion in Period 1 and the first dose of danicopan in Period 2.

    Drug: Danicopan · Drug: Bupropion

  • Experimental
    Part 3: Danicopan and EE/NET

    Period 1: Participants received a single dose of EE/NET. Period 2: Participants received danicopan three times daily, in addition to coadministration with a single dose of EE/NET. Scheduled PK samples were collected, with a washout period of at least 7 days between the dose of EE/NET in Period 1 and the first dose of danicopan in Period 2.

    Drug: Danicopan · Drug: Ethinyl Estradiol/Norethindrone

Interventions

  • DrugDanicopan

    Danicopan was dosed as 2 x 100 milligram (mg) tablets.

    Also known as: ACH-0144471, ALXN2040

  • DrugWarfarin

    Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent).

    Also known as: Coumadin

  • DrugBupropion

    Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet.

    Also known as: Bupropion HCl, Wellbutrin

  • DrugEthinyl Estradiol/Norethindrone

    EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets.

    Also known as: Ortho-Novum

06

What researchers measure

Primary outcomes

  1. Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Warfarin Under Multiple Doses Of Danicopan

    Time frame: Up to 168 hours postdose

  2. Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Warfarin Under Multiple Doses Of Danicopan

    Time frame: Up to 168 hours postdose

  3. Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Warfarin Under Multiple Doses Of Danicopan

    Time frame: Up to 168 hours postdose

  4. Part 2: AUC0-inf Of Single-dose Bupropion Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

  5. Part 2: Cmax Of Single-dose Bupropion Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

  6. Part 2: Tmax Of Single-dose Bupropion Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

  7. Part 3: AUC0-inf Of Single-dose EE/NET Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

  8. Part 3: Cmax Of Single-dose EE/NET Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

  9. Part 3: Tmax Of Single-dose EE/NET Under Multiple Doses Of Danicopan

    Time frame: Up to 96 hours postdose

Secondary outcomes

  1. Part 1: International Normalized Ratio (INR) Of Single-dose Warfarin Under Multiple Doses Of Danicopan

    Blood samples will be collected for prothrombin time/INR determination.

    Time frame: Up to 168 hours postdose

  2. Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of Danicopan Coadministered With A Single Dose Of Warfarin

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

  3. Part 2: Number Of Participants With TEAEs After Multiple Doses Of Danicopan Coadministered With A Single Dose Of Bupropion

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

  4. Part 3: Number Of Participants With TEAEs After Multiple Doses Of Danicopan Coadministered With A Single Dose Of EE/NET

    Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)

07

Study locations

1 site
  • Clinical Study Site
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04709094
Lead sponsor
Alexion Pharmaceuticals, Inc.
Collaborators
Achillion, a wholly owned subsidiary of Alexion, Celerion
Responsible party
Sponsor
First posted
Jan 14, 2021
Start date
Jul 28, 2019
Primary completion
Oct 14, 2019
Completion
Apr 17, 2020
Last update
Jan 14, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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