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HealthyPhase 1NCT04709094

A Drug Interaction Study of Danicopan

A Phase 1 study testing Danicopan, Warfarin and Bupropion in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Danicopan, Warfarin and Bupropion
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
28 Jul 2019to 17 Apr 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • No clinically significant history or presence of electrocardiogram abnormalities at screening.
  • Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
  • Female participants must be of non-childbearing potential and need not employ a method of contraception.
  • Part 1 only: Participant has a negative fecal occult blood test at screening.

Who cannot join

  • Clinically significant laboratory abnormalities.
  • 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/nicotine user, or positive for alcohol and/or drug screen at screening or Day -1 of Period 1.
  • History or presence of clinically significant seizures, head injury, or head trauma.
  • History of procedures that could alter absorption or excretion of orally administered drugs.
  • History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
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  • A 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°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.
  • 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.
  • 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:
  • 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.
  • Has active severe gingivitis.
  • Clinically significant illness, clinically significant surgery, including tooth extraction, trauma, or head injury, within 28 days before Day 1 of Period 1.
  • 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).
  • 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:
  • Any significant finding on the Columbia-suicide severity rating scale.
  • 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:
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Study Site

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Three-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0144471 and Warfarin, Bupropion, and Ethinyl Estradiol and Norethindrone (Oral Contraceptive) in Healthy Adult Subjects

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).

Conditions
Healthy
Being tested
Danicopan, Warfarin, Bupropion, Ethinyl Estradiol/Norethindrone
Keywords
Factor D Inhibitor, Complement, Danicopan, Oral Contraceptive, Pharmacokinetics, Pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DanicopanDrug

    Also called ACH-0144471, ALXN2040

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

  • WarfarinDrug

    Also called Coumadin

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

  • BupropionDrug

    Also called Bupropion HCl, Wellbutrin

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

  • Ethinyl Estradiol/NorethindroneDrug

    Also called Ortho-Novum

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

Study groups in NCT04709094
Study groupRoleWhat they receive
Part 1: Danicopan and WarfarinExperimentalPeriod 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.
Receives: Drug: Danicopan; Drug: Warfarin
Part 2: Danicopan and BupropionExperimentalPeriod 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.
Receives: Drug: Danicopan; Drug: Bupropion
Part 3: Danicopan and EE/NETExperimentalPeriod 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.
Receives: Drug: Danicopan; Drug: Ethinyl Estradiol/Norethindrone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 168 hours postdose

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

    Measured: Up to 168 hours postdose

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

    Measured: Up to 168 hours postdose

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

    Measured: Up to 96 hours postdose

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

    Measured: Up to 96 hours postdose

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

    Measured: Up to 96 hours postdose

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

    Measured: Up to 96 hours postdose

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

    Measured: Up to 96 hours postdose

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

    Measured: Up to 96 hours postdose

Secondary outcomes (4)

  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.

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start28 Jul 2019
  3. Primary completion14 Oct 2019
  4. Study completion17 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1, Part 2, and Part 3 could be conducted concurrently or separately.
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04709094
Sponsor's protocol ID
ACH471-017
Other IDs
CA27858
Status last verified
Jan 2021
First submitted
12 Jan 2021
Last updated
14 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Danicopan, Warfarin and Bupropion in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04709094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.

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