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HealthyPhase 1NCT04709081

A Drug Interaction Study of ACH-0145228

A Phase 1 study testing ACH-0145228, Midazolam and Digoxin 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 2-part study (Part 1 and Part 2), 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?
ACH-0145228, Midazolam and Digoxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
22 Dec 2019to 16 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 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.
  • No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1.
  • 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.

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.
  • A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
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  • Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1.
  • 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.
  • History or presence of any risk factors for Torsades de Pointes.

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 Two-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0145228 and Midazolam, Digoxin, and Itraconazole in Healthy Adult Subjects

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

Conditions
Healthy
Being tested
ACH-0145228, Midazolam, Digoxin, Itraconazole
Keywords
Factor D Inhibitor, Complement, Capsule, Pharmacokinetics, Drug Interaction

What participants receive

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

  • ACH-0145228Drug

    Also called ALXN2050

    ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.

  • MidazolamDrug

    Also called Midazolam HCl

    Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).

  • DigoxinDrug

    Also called Lanoxin

    Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.

  • ItraconazoleDrug

    Also called Sporanox

    Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).

Study groups in NCT04709081
Study groupRoleWhat they receive
Part 1: ACH-0145228, Midazolam, and DigoxinExperimentalPeriod 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2.
Receives: Drug: ACH-0145228; Drug: Midazolam; Drug: Digoxin
Part 2: ACH-0145228 and ItraconazoleExperimentalPeriod 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2.
Receives: Drug: ACH-0145228; Drug: Itraconazole

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 Midazolam Under Multiple Doses Of ACH-0145228

    Measured: Up to 24 hours postdose

  2. Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228

    Measured: Up to 24 hours postdose

  3. Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228

    Measured: Up to 24 hours postdose

  4. Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Measured: Up to 168 hours postdose

  5. Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Measured: Up to 168 hours postdose

  6. Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228

    Measured: Up to 168 hours postdose

  7. Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Measured: Up to 96 hours postdose

  8. Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Measured: Up to 96 hours postdose

  9. Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole

    Measured: Up to 96 hours postdose

Secondary outcomes (3)

  1. Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam

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

  2. Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin

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

  3. Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole

    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 start22 Dec 2019
  3. Primary completion16 Apr 2020
  4. Study completion16 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 and Part 2 could be conducted concurrently or separately.
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04709081
Sponsor's protocol ID
ACH228-003
Other IDs
CA28776
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 ACH-0145228, Midazolam and Digoxin 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 10 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 Midazolam Under Multiple Doses Of ACH-0145228 (time frame: Up to 24 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 NCT04709081.

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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