HealthyPhase 1NCT04940559
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
A Phase 1 study testing Danicopan - Tablet, Danicopan - Softgel and Danicopan - LFC in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in New Zealand.
Trial summary
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy 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 - Tablet, Danicopan - Softgel and Danicopan - LFC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Aug 2016to 5 Oct 2016
- 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
- Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Who cannot join
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- History of procedures that could alter absorption of orally administered drugs.
- Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
- Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
- Participation in a clinical study within 30 days prior to study drug administration.
- Clinically significant laboratory abnormalities at Screening or Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
- Conditions
- Healthy
- Being tested
- Danicopan - Tablet, Danicopan - Softgel, Danicopan - LFC
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Relative Bioavailability, LFC, Tablet, Softgel Capsule, Food Effect, Pharmacokinetics, Factor D Inhibitor, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danicopan - TabletDrug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Oral tablet.
Danicopan - SoftgelDrug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Oral softgel capsule.
Danicopan - LFCDrug
Also called ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471
Oral LFC.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sequence 1 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. Receives: Drug: Danicopan - Tablet; Drug: Danicopan - LFC |
| Group 1: Sequence 2 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. Receives: Drug: Danicopan - Tablet; Drug: Danicopan - LFC |
| Group 1: Sequence 3 | Experimental | Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. Receives: Drug: Danicopan - Tablet; Drug: Danicopan - LFC |
| Group 2: Sequence 1 | Experimental | Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. Receives: Drug: Danicopan - Softgel; Drug: Danicopan - LFC |
| Group 2: Sequence 2 | Experimental | Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. Receives: Drug: Danicopan - Softgel; Drug: Danicopan - LFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
Measured: Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
Measured: Up to 96 hours postdose
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
Measured: Up to 96 hours postdose
Secondary outcomes (4)
PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Measured: Up to 96 hours postdose
PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Measured: Up to 96 hours postdose
PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Measured: Up to 96 hours postdose
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation
Measured: Day 1 through Day 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start2 Aug 2016
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
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
- Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT04940559
- Sponsor's protocol ID
- ACH471-006
- Other IDs
- ACTRN12616001017415
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04940559
- Acronym / sponsor ID
- ACH471-006
- Conditions
- Healthy
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Relative Bioavailability, LFC, Tablet, Softgel Capsule, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 25 Jun 2021 (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 was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sequence 1 | Experimental | Drug: Danicopan - Tablet, Drug: Danicopan - LFCParticipants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
| Group 1: Sequence 2 | Experimental | Drug: Danicopan - Tablet, Drug: Danicopan - LFCParticipants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
| Group 1: Sequence 3 | Experimental | Drug: Danicopan - Tablet, Drug: Danicopan - LFCParticipants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows: Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
| Group 2: Sequence 1 | Experimental | Drug: Danicopan - Softgel, Drug: Danicopan - LFCParticipants received danicopan once each period as a single dose under fasted conditions as follows: Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
| Group 2: Sequence 2 | Experimental | Drug: Danicopan - Softgel, Drug: Danicopan - LFCParticipants received danicopan once each period as a single dose under fasted conditions as follows: Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.
Key exclusion criteria (6 listed)
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- History of procedures that could alter absorption of orally administered drugs.
- Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
- Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
- Participation in a clinical study within 30 days prior to study drug administration.
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 - TabletAlso: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Oral tablet. | Drug | Group 1: Sequence 1, Group 1: Sequence 2, Group 1: Sequence 3 |
| Danicopan - SoftgelAlso: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Oral softgel capsule. | Drug | Group 2: Sequence 1, Group 2: Sequence 2 |
| Danicopan - LFCAlso: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Oral LFC. | Drug | Group 1: Sequence 1, Group 1: Sequence 2, Group 1: Sequence 3, Group 2: Sequence 1, Group 2: Sequence 2 |
Primary outcome
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
Time frame: Up to 96 hours postdose
4 secondary outcomes
PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time frame: Up to 96 hours postdose
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation
Time frame: Day 1 through Day 39
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 25 Jun 2021.
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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 - Tablet, Danicopan - Softgel and Danicopan - LFC in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in New Zealand.
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 2 inclusion and 6 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 25 Jun 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 New Zealand. 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?
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations (time frame: Up to 96 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 25 Jun 2021.