HealthyPhase 1NCT03384186
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
A Phase 1 study testing Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2 and Danicopan Modified Release Prototype 3 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations. 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 Modified Release Prototype 1, Danicopan Modified Release Prototype 2 and Danicopan Modified Release Prototype 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to 21 Mar 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 of 18.0 to 30.0 kilograms/square meter.
- Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
- Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.
Who cannot join
- Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
- Clinically significant laboratory abnormalities.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
- History or family history of meningococcal infection.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
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- Presence or history of clinically significant allergy requiring treatment.
- Donation or loss of greater than 400 milliliters of blood within the previous 3 months.
- Note: Other inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Trial Site
Ruddington, Nottingham, NG111 6JS
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
- Conditions
- Healthy
- Being tested
- Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2, Danicopan Modified Release Prototype 3
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Pharmacokinetics, Modified Release, Factor D Inhibitor, Relative Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danicopan Modified Release Prototype 1Drug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Danicopan (400 milligrams [mg]) oral tablet.
Danicopan Modified Release Prototype 2Drug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Danicopan (400 mg) oral tablet.
Danicopan Modified Release Prototype 3Drug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Danicopan (800 mg) oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Danicopan Modified Release Prototype Tablets | Experimental | Participants received danicopan once each period as a single oral dose as follows:
Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions.
There was a washout period of at least 14 days between each danicopan dosing. Receives: Drug: Danicopan Modified Release Prototype 1; Drug: Danicopan Modified Release Prototype 2; Drug: Danicopan Modified Release Prototype 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation
Measured: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation
Measured: Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation
Measured: Up to 72 hours postdose
Secondary outcomes (1)
Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up visit (10 [+/- 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 posted27 Dec 2017
- Study start1 Dec 2017
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384186
- Sponsor's protocol ID
- ACH471-011
- Other IDs
- 2017-003525-15, 2017
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2017
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03384186
- Acronym / sponsor ID
- ACH471-011
- Conditions
- Healthy
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Pharmacokinetics, Modified Release, Factor D Inhibitor, Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 27 Dec 2017 (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.
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danicopan Modified Release Prototype Tablets | Experimental | Drug: Danicopan Modified Release Prototype 1, Drug: Danicopan Modified Release Prototype 2, Drug: Danicopan Modified Release Prototype 3Participants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 18.0 to 30.0 kilograms/square meter.
- Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception.
- Male participants must either agree to abstinence or use of a condom plus an effective method of contraception.
Key exclusion criteria (9 listed)
- Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months.
- History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result.
- Clinically significant laboratory abnormalities.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
- History or family history of meningococcal infection.
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 |
|---|---|---|
| Danicopan Modified Release Prototype 1Also: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Danicopan (400 milligrams [mg]) oral tablet. | Drug | Danicopan Modified Release Prototype Tablets |
| Danicopan Modified Release Prototype 2Also: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Danicopan (400 mg) oral tablet. | Drug | Danicopan Modified Release Prototype Tablets |
| Danicopan Modified Release Prototype 3Also: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Danicopan (800 mg) oral tablet. | Drug | Danicopan Modified Release Prototype Tablets |
Primary outcome
Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation
Time frame: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation
Time frame: Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation
Time frame: Up to 72 hours postdose
1 secondary outcome
Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up visit (10 [+/- 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 20 Aug 2021.
- Individual participant dataSharing planned: Yes
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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 Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2 and Danicopan Modified Release Prototype 3 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
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 3 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 20 Aug 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 Kingdom. 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?
Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation (time frame: Up to 72 hours postdose). The study lists 3 primary outcomes in all. 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 20 Aug 2021.