HealthyPhase 1NCT04609696
Study of the Metabolism of Danicopan in Healthy Adults
A Phase 1 study testing Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2 and Danicopan: Tablet in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan 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?
- Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2 and Danicopan: Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 7 Dec 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
- No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
- 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.
- Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
Who cannot join
- 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, or positive drugs-of-abuse screen 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.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- 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°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
Show all 9Show fewer
- 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.
- Is a female with a positive pregnancy test or who is lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
Read the detailed description
For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.
- Conditions
- Healthy
- Being tested
- Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2, Danicopan: Tablet
- Keywords
- Tablet, Capsule, Danicopan, Bioavailability, Factor D Inhibitor, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danicopan: Powder-In-Capsule 1Drug
Also called ALXN2040, ACH-0144471 (formerly)
Danicopan (200 milligrams) will be administered orally on Day 1.
Danicopan: Powder-In-Capsule 2Drug
Also called ALXN2040, ACH-0144471 (formerly)
Danicopan (200 milligrams) will be administered orally on Day 1.
Danicopan: TabletDrug
Also called ALXN2040, ACH-0144471 (formerly)
Danicopan (200 milligrams) will be administered orally on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 1; Drug: Danicopan: Tablet |
| Part 1: Sequence 2 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 1; Drug: Danicopan: Tablet |
| Part 1: Sequence 3 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 1; Drug: Danicopan: Tablet |
| Part 2: Sequence 1 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 2; Drug: Danicopan: Tablet |
| Part 2: Sequence 2 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 2; Drug: Danicopan: Tablet |
| Part 2: Sequence 3 | Experimental | Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing. Receives: Drug: Danicopan: Powder-In-Capsule 2; Drug: Danicopan: Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
Measured: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.
Measured: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Measured: Up to 72 hours postdose
Secondary outcomes (4)
Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Measured: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions
Measured: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Measured: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions
Measured: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start20 Oct 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609696
- Sponsor's protocol ID
- ALXN2040-HV-119
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2020
- Last updated
- 15 Apr 2022
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04609696
- Acronym / sponsor ID
- ALXN2040-HV-119
- Conditions
- Healthy
- Keywords
- Tablet, Capsule, Danicopan, Bioavailability, Factor D Inhibitor, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 30 Oct 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 is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
Detailed description
For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Sequence 1 | Experimental | Drug: Danicopan: Powder-In-Capsule 1, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 1 formulation under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
| Part 1: Sequence 2 | Experimental | Drug: Danicopan: Powder-In-Capsule 1, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
| Part 1: Sequence 3 | Experimental | Drug: Danicopan: Powder-In-Capsule 1, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fasted conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
| Part 2: Sequence 1 | Experimental | Drug: Danicopan: Powder-In-Capsule 2, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 2 formulation under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
| Part 2: Sequence 2 | Experimental | Drug: Danicopan: Powder-In-Capsule 2, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
| Part 2: Sequence 3 | Experimental | Drug: Danicopan: Powder-In-Capsule 2, Drug: Danicopan: TabletParticipants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows: Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions. There will be a washout period of at least 5 days between each danicopan dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
- 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.
- Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
Key exclusion criteria (9 listed)
- 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, or positive drugs-of-abuse screen 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.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription 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 |
|---|---|---|
| Danicopan: Powder-In-Capsule 1Also: ALXN2040, ACH-0144471 (formerly)Danicopan (200 milligrams) will be administered orally on Day 1. | Drug | Part 1: Sequence 1, Part 1: Sequence 2, Part 1: Sequence 3 |
| Danicopan: Powder-In-Capsule 2Also: ALXN2040, ACH-0144471 (formerly)Danicopan (200 milligrams) will be administered orally on Day 1. | Drug | Part 2: Sequence 1, Part 2: Sequence 2, Part 2: Sequence 3 |
| Danicopan: TabletAlso: ALXN2040, ACH-0144471 (formerly)Danicopan (200 milligrams) will be administered orally on Day 1. | Drug | Part 1: Sequence 1, Part 1: Sequence 2, Part 1: Sequence 3, Part 2: Sequence 1, Part 2: Sequence 2, Part 2: Sequence 3 |
Primary outcome
Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
Time frame: Up to 72 hours postdose
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
Time frame: Up to 72 hours postdose
The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.
AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
Time frame: Up to 72 hours postdose
4 secondary outcomes
Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1)
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 Apr 2022.
- 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: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2 and Danicopan: Tablet 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 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 15 Apr 2022. 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 Danicopan Prototype PIC 1 Formulation And Tablet Formulation (time frame: Up to 72 hours postdose). The study lists 10 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 Apr 2022.