HealthyPhase 1NCT04551599
A Study of the Effects of Food and Age on Danicopan
A Phase 1 study testing Danicopan in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 3 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adult males or females, between 18 and 55 years of age (Part 1 only).
- Elderly male participants aged ≥ 65 years of age at screening (Part 2 only).
- 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 of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception (Part 1 only).
Who cannot join
- Clinically significant laboratory abnormalities.
- Pregnant or lactating (Part 1 only).
- 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 or alcohol screen at screening or Day -1 of Period 1.
- History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- 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.
Show all 11Show fewer
- 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.
- Major surgery within previous 4 weeks.
- 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.
- 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, or receipt of a vaccine within 30 days prior to (first) dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Open-Label Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of Danicopan
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
Read the detailed description
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
- Conditions
- Healthy
- Being tested
- Danicopan
- Keywords
- Factor D Inhibitor, Complement, Danicopan, Pharmacokinetics, Food-effect, Age-effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanicopanDrug
Also called ACH-0144471, ALXN2040
A single dose of danicopan (200 milligrams) will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Healthy, young, adult participants will receive danicopan once each Period as follows:
Period 1: Danicopan administered under fed conditions.
Period 2: Danicopan administered under fasted conditions.
There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. Receives: Drug: Danicopan |
| Part 1: Sequence 2 | Experimental | Healthy, young, adult participants will receive danicopan once each Period as follows:
Period 1: Danicopan administered under fasted conditions.
Period 2: Danicopan administered under fed conditions.
There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. Receives: Drug: Danicopan |
| Part 2 | Experimental | Healthy, elderly, male participants will receive a single dose of danicopan under fed conditions. Receives: Drug: Danicopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Measured: Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Measured: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Measured: Up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Measured: Up to 72 hours postdose
AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males
Measured: Up to 72 hours postdose
AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males
Measured: Up to 72 hours postdose
Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Measured: Up to 72 hours postdose
Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Measured: Up to 72 hours postdose
Secondary outcomes (1)
Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up (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 posted16 Sep 2020
- Study start21 Feb 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
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 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover study, and Part 2 will be a 1-period study.
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT04551599
- Sponsor's protocol ID
- ACH471-016
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open-Label Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of Danicopan
- ClinicalTrials.gov ID
- NCT04551599
- Acronym / sponsor ID
- ACH471-016
- Conditions
- Healthy
- Keywords
- Factor D Inhibitor, Complement, Danicopan, Pharmacokinetics, Food-effect, Age-effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (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, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
Detailed description
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This will be 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover study, and Part 2 will be a 1-period study.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Drug: DanicopanHealthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fed conditions. Period 2: Danicopan administered under fasted conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. |
| Part 1: Sequence 2 | Experimental | Drug: DanicopanHealthy, young, adult participants will receive danicopan once each Period as follows: Period 1: Danicopan administered under fasted conditions. Period 2: Danicopan administered under fed conditions. There will be a washout period of at least 7 days between the dose of danicopan in Period 1 and the dose of danicopan in Period 2. |
| Part 2 | Experimental | Drug: DanicopanHealthy, elderly, male participants will receive a single dose of danicopan under fed conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Young adult males or females, between 18 and 55 years of age (Part 1 only).
- Elderly male participants aged ≥ 65 years of age at screening (Part 2 only).
- 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.
Key exclusion criteria (11 listed)
- Clinically significant laboratory abnormalities.
- Pregnant or lactating (Part 1 only).
- 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 or alcohol screen at screening or Day -1 of Period 1.
- History of meningococcal infection, or a first-degree relative with a 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 |
|---|---|---|
| DanicopanAlso: ACH-0144471, ALXN2040A single dose of danicopan (200 milligrams) will be administered orally. | Drug | Part 1: Sequence 1, Part 1: Sequence 2, Part 2 |
Primary outcome
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Time frame: Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Time frame: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Time frame: Up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
1 secondary outcome
Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (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 13 Jan 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 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 6 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 13 Jan 2023. 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?
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults (time frame: Up to 72 hours postdose). The study lists 8 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 13 Jan 2023.