HealthyPhase 1NCT04551586
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
A Phase 1 study testing ACH-0145228: Immediate Release and ACH-0145228: Powder-in-capsule in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule. 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: Immediate Release and ACH-0145228: Powder-in-capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2020to 19 Oct 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 findings 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.
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 user, and positive drugs-of-abuse screen and alcohol 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.
- Is a female of childbearing potential.
- Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess the Relative Bioavailability of ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Subjects
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
- Conditions
- Healthy
- Being tested
- ACH-0145228: Immediate Release, ACH-0145228: Powder-in-capsule
- Keywords
- Factor D Inhibitor, Complement, Bioavailability, Tablet, Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH-0145228: Immediate ReleaseDrug
Also called ALXN2050
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
ACH-0145228: Powder-in-capsuleDrug
Also called ALXN2050
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference).
There will be a washout period of at least 5 days between each ACH-0145228 dosing. Receives: Drug: ACH-0145228: Immediate Release; Drug: ACH-0145228: Powder-in-capsule |
| Sequence 2 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference).
Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
There will be a washout period of at least 5 days between each ACH-0145228 dosing. Receives: Drug: ACH-0145228: Immediate Release; Drug: ACH-0145228: Powder-in-capsule |
| Sequence 3 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows:
Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference).
Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted).
Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed).
There will be a washout period of at least 5 days between each ACH-0145228 dosing. Receives: Drug: ACH-0145228: Immediate Release; Drug: ACH-0145228: Powder-in-capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
Measured: Up to 72 hours postdose
Secondary outcomes (9)
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Measured: Up to 72 hours postdose
AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Measured: Up to 72 hours postdose
Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Measured: Up to 72 hours postdose
Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Measured: Up to 72 hours postdose
Number Of Participants With Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up (30 [+/- 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.
- First posted16 Sep 2020
- Study start26 Jun 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- This will be a 3-sequence, 3-period crossover study in healthy adult participants.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551586
- Sponsor's protocol ID
- ACH228-004
- Status last verified
- Nov 2021
- First submitted
- 10 Sep 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Relative Bioavailability of ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04551586
- Acronym / sponsor ID
- ACH228-004
- Conditions
- Healthy
- Keywords
- Factor D Inhibitor, Complement, Bioavailability, Tablet, Capsule
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This will be a 3-sequence, 3-period crossover study in healthy adult participants.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: ACH-0145228: Immediate Release, Drug: ACH-0145228: Powder-in-capsuleParticipants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
| Sequence 2 | Experimental | Drug: ACH-0145228: Immediate Release, Drug: ACH-0145228: Powder-in-capsuleParticipants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
| Sequence 3 | Experimental | Drug: ACH-0145228: Immediate Release, Drug: ACH-0145228: Powder-in-capsuleParticipants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 findings 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.
Key exclusion criteria (11 listed)
- 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 user, and positive drugs-of-abuse screen and alcohol 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACH-0145228: Immediate ReleaseAlso: ALXN2050ACH-0145228 (240 milligrams) will be administered orally on Day 1. | Drug | Sequence 1, Sequence 2, Sequence 3 |
| ACH-0145228: Powder-in-capsuleAlso: ALXN2050ACH-0145228 (240 milligrams) will be administered orally on Day 1. | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
Time frame: Up to 72 hours postdose
Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
9 secondary outcomes
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Time frame: Up to 72 hours postdose
Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Time frame: Up to 72 hours postdose
Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
Time frame: Up to 72 hours postdose
Number Of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACH-0145228: Immediate Release and ACH-0145228: Powder-in-capsule 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 11 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 28 Dec 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?
Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule (time frame: Up to 72 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2021.