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HealthyPhase 1NCT05109390

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

A Phase 1 study testing Danicopan, Cyclosporine and Tacrolimus 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 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 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Danicopan, Cyclosporine and Tacrolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
27 Jul 2018to 17 Oct 2018
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 must have been of non-childbearing potential and not needing to employ a method of contraception.
  • Non-sterile male participants must have agreed to abstinence or used a highly effective method of contraception.
  • No clinically significant history or presence of electrocardiogram findings at Screening and Day -1 of Period 1.

Who cannot join

  • Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.
  • History of any medical or psychiatric condition or disease that might have limited 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 2 years prior to first dosing; current tobacco/nicotine users and smokers; positive drugs-of-abuse and/or alcohol screen at Screening or Day -1 of Period 1.
  • Any previous procedure that could have altered absorption or excretion of orally administered drugs.
  • A history of significant multiple and/or severe allergies or had had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
  • Body temperature ≥ 38°Celsius at Screening, on Day -1, or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.
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  • 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 was 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.
  • Part 3 Only: Genotyped as poor metabolizer of cytochrome P450 2C19.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Trial 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 Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adult Subjects

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

Conditions
Healthy
Being tested
Danicopan, Cyclosporine, Tacrolimus, Calcium Carbonate, Aluminum/Magnesium Hydroxide/Simethicone
Keywords
Danicopan, ALXN2040, ACH-0144471, Drug Interaction, Cyclosporine, Tacrolimus, Antacids, Omeprazole

What participants receive

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

  • DanicopanDrug

    Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471

    Oral tablet.

  • CyclosporineDrug

    Also called Neoral

    Oral capsule.

  • TacrolimusDrug

    Also called Prograf

    Oral capsule.

  • Calcium CarbonateDrug

    Also called Antacid

    Chewable tablet.

  • Aluminum/Magnesium Hydroxide/SimethiconeDrug

    Also called Antacid, Gelusil

    Chewable tablet.

  • OmeprazoleDrug

    Also called Prilosec

    Oral, delayed-release capsule.

Study groups in NCT05109390
Study groupRoleWhat they receive
Part 1: Danicopan plus CyclosporineExperimentalParticipants (N=14) received danicopan and cyclosporine in a fixed sequence over 2 periods: Treatment A (Period 1): 300 milligrams (mg) cyclosporine administered on Day 1. Treatment B (Period 2): 200 mg danicopan administered 3 times daily (TID) on Days 1-7 with 300 mg cyclosporine coadministered on Day 5. There was a washout period of 3 days between the dose of cyclosporine in Period 1 and the first dose of danicopan in Period 2.
Receives: Drug: Danicopan; Drug: Cyclosporine
Part 2: Danicopan plus TacrolimusExperimentalParticipants (N=28) received danicopan and tacrolimus in a fixed sequence over 2 periods: Treatment C (Period 1): 2 mg tacrolimus administered on Day 1. Treatment D (Period 2): 200 mg danicopan administered TID on Days 1-10 with 2 mg tacrolimus coadministered on Day 5. There was a washout period of 7 days between the dose of tacrolimus in Period 1 and the first dose of danicopan in Period 2.
Receives: Drug: Danicopan; Drug: Tacrolimus
Part 3: Danicopan plus Antacids and OmeprazoleExperimentalParticipants (N=30) received danicopan, calcium carbonate, aluminum/magnesium hydroxide/simethicone, and omeprazole in fixed sequences over 2 periods: Treatment E1 (Period 1): 200 mg danicopan administered TID on Days 1-4. Treatment E2 (Period 1): 200 mg danicopan coadministered with 1 gram calcium carbonate on Day 5. Treatment F1 (Period 1): 200 mg danicopan administered TID on Days 1-4. Treatment F2 (Period 1): 200 mg danicopan coadministered with 200 mg aluminum hydroxide/200 magnesium hydroxide/25 mg simethicone on Day 5. Note: Participants were randomized in a 1:1 ratio to receive either Treatment E2 or F2 coadministered with danicopan on Day 5. Treatment G1 (Period 2): 40 mg omeprazole administered once daily (QD) on Days 1-4. Treatment G2 (Period 2): 40 mg omeprazole administered QD with 200 mg danicopan administered orally TID on Days 5-8. There was a washout period of 2 days between the last dose of danicopan in Period 1 and the first dose of omeprazole in Period 2.
Receives: Drug: Danicopan; Drug: Calcium Carbonate; Drug: Aluminum/Magnesium Hydroxide/Simethicone; Drug: Omeprazole

What is being measured

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

  1. Part 1: Cyclosporine Maximum Observed Concentration (Cmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 72 hours postdose

  2. Part 1: Cyclosporine Time To Reach The Maximum Observed Concentration (Tmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 72 hours postdose

  3. Part 1: Cyclosporine Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 72 hours postdose

  4. Part 2: Tacrolimus Cmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 144 hours postdose

  5. Part 2: Tacrolimus Tmax Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 144 hours postdose

  6. Part 2: Tacrolimus AUC0-inf Following Single-dose Tacrolimus Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 144 hours postdose

  7. Part 3: Steady-state Omeprazole Cmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 24 hours postdose

  8. Part 3: Steady-state Omeprazole Tmax Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 24 hours postdose

  9. Part 3: Steady-state Omeprazole Area Under The Concentration-time Curve From Time 0 To The 24-hour Time Point (AUC0-24) Following Multiple-dose Omeprazole Alone Versus In The Presence Of Steady-state Danicopan

    Measured: Up to 24 hours postdose

  10. Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Multiple-dose Omeprazole

    Measured: Up to 8 hours postdose

  11. Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Multiple-dose Omeprazole

    Measured: Up to 8 hours postdose

  12. Part 3: Steady-state Danicopan Area Under The Concentration-time Curve From Time 0 To The 8-hour Time Point (AUC0-8) Alone Versus In The Presence Of Multiple-dose Omeprazole

    Measured: Up to 8 hours postdose

  13. Part 3: Steady-state Danicopan Cmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Measured: Up to 8 hours postdose

  14. Part 3: Steady-state Danicopan Tmax Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Measured: Up to 8 hours postdose

  15. Part 3: Steady-state Danicopan AUC0-8 Alone Versus In The Presence Of Single-dose Calcium Carbonate Or Aluminum/Magnesium Hydroxide/Simethicone

    Measured: Up to 8 hours postdose

Secondary outcomes (1)

  1. Number Of Participants Experiencing Treatment-emergent Adverse Events

    Measured: Day 1 through up to Day 31

Timeline

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

  1. First posted5 Nov 2021
  2. Study start27 Jul 2018
  3. Primary completion17 Oct 2018
  4. Study completion17 Oct 2018

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
Non-randomised
Intervention model
Parallel groups
Model description
This was a 3-part study, each part is a fixed-sequence with 2 periods.
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05109390
Sponsor's protocol ID
ACH471-014
Status last verified
Nov 2021
First submitted
9 Sep 2021
Last updated
5 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Danicopan, Cyclosporine and Tacrolimus 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 4 inclusion and 9 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 5 Nov 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: Cyclosporine Maximum Observed Concentration (Cmax) Following Single-dose Cyclosporine Alone Versus In The Presence Of Steady-state Danicopan (time frame: Up to 72 hours postdose). The study lists 15 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 NCT05109390.

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 5 Nov 2021.

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