HealthyPhase 1NCT04451434
Study of Danicopan in Participants of Japanese Descent
A Phase 1 study testing Danicopan in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Australia.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Aug 2020to 28 Sep 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
- Participants who are of Japanese descent defined as:
- First generation (born to 2 Japanese parents and 4 Japanese grandparents)
- Born in Japan, and not have lived outside Japan for greater than 10 years
- Lifestyle, including diet, must not have significantly changed since leaving Japan
- No clinically significant history or presence of electrocardiogram findings as judged by the Investigator at screening and prior to the first dose of study intervention in Period 1.
- Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meters squared, inclusive, with a minimum body weight of 50.0 kg at screening.
Who cannot join
- Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, 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 clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents.
- History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention.
- Any major surgery within 4 weeks of the first dose of study intervention.
Show all 18Show fewer
- Diagnosis or history of Gilbert's syndrome, in the opinion of the Investigator or designee.
- Unable to refrain from or anticipates the use of any drug.
- Receipt of a vaccine within 30 days prior to the first dose of study intervention.
- Receipt of blood products within 6 months prior to the first dose of study intervention.
- 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 prior to the first dose of study intervention, whichever is longer.
- Seated blood pressure is less than 90/40 millimeters of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Participants who test positive for human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus.
- Current tobacco users and smokers or a positive cotinine test at screening.
- Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention.
- Positive drugs of abuse screen at screening or Day -1 of Period 1.
- Positive results for alcohol screen at screening or Day -1 of Period 1.
- Is a female with a positive pregnancy test at screening or Day -1 of Period 1 or who is lactating, or who plan to become pregnant (within 5 months of screening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
Read the detailed description
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent.
On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention.
Safety will be assessed throughout the study.
- Conditions
- Healthy
- Being tested
- Danicopan
- Keywords
- Factor D inhibitor, Complement, Danicopan, Pharmacokinetics, Japanese, Food
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
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Danicopan 200 mg Fasted | Experimental | Fasting participants will receive a single dose of 200 mg danicopan. Receives: Drug: Danicopan |
| Danicopan 200 mg Fed | Experimental | Fed participants will receive a single dose of 200 mg danicopan. Receives: Drug: Danicopan |
| Danicopan 400 mg Fed | Experimental | Fed participants will receive a single dose of 400 mg danicopan. Receives: Drug: Danicopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Treatment-Emergent Adverse Events
Measured: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)
Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States
Measured: up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States
Measured: up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States
Measured: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by AUC
Measured: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by Cmax
Measured: up to 72 hours postdose
Secondary outcomes (2)
Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay
Blood samples will be collected for measurement of danicopan activity.
Measured: up to 72 hours postdose
Complement Factor B Fraction b Levels
Blood samples will be collected for measurement of complement factor B fraction b levels.
Measured: up to 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start17 Aug 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-way crossover
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT04451434
- Sponsor's protocol ID
- ALXN2040-HV-101
- Status last verified
- Feb 2021
- First submitted
- 19 Jun 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent
- ClinicalTrials.gov ID
- NCT04451434
- Acronym / sponsor ID
- ALXN2040-HV-101
- Conditions
- Healthy
- Keywords
- Factor D inhibitor, Complement, Danicopan, Pharmacokinetics, Japanese, Food
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 30 Jun 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 study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
Detailed description
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent.
On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention.
Safety will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-way crossover
| Arm | Type | Receives |
|---|---|---|
| Danicopan 200 mg Fasted | Experimental | Drug: DanicopanFasting participants will receive a single dose of 200 mg danicopan. |
| Danicopan 200 mg Fed | Experimental | Drug: DanicopanFed participants will receive a single dose of 200 mg danicopan. |
| Danicopan 400 mg Fed | Experimental | Drug: DanicopanFed participants will receive a single dose of 400 mg danicopan. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who are of Japanese descent defined as:
- No clinically significant history or presence of electrocardiogram findings as judged by the Investigator at screening and prior to the first dose of study intervention in Period 1.
- Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meters squared, inclusive, with a minimum body weight of 50.0 kg at screening.
Key exclusion criteria (18 listed)
- Evidence of any clinically significant deviation from normal in clinical laboratory evaluations, as determined by the Investigator or designee.
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, 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 clinically significant hypersensitivity or idiosyncratic reaction to the study interventions or related compounds or commonly used antibacterial agents.
- History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- History of febrile illness, or other evidence of infection, within 14 days prior to the first dose of study intervention.
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 |
|---|---|---|
| DanicopanAlso: ALXN2040, ACH-0144471Oral tablet | Drug | Danicopan 200 mg Fasted, Danicopan 200 mg Fed, Danicopan 400 mg Fed |
Primary outcome
Number Of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)
Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by AUC
Time frame: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by Cmax
Time frame: up to 72 hours postdose
2 secondary outcomes
Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay
Time frame: up to 72 hours postdose
Complement Factor B Fraction b Levels
Time frame: up to 72 hours postdose
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 15 Feb 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 Danicopan in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Australia.
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 18 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 15 Feb 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 Australia. 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?
Number Of Participants With Treatment-Emergent Adverse Events (time frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)). The study lists 6 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 15 Feb 2021.