HealthyPhase 1NCT03108274
A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants
A Phase 1 study testing Danicopan, Midazolam and Fexofenadine in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in New Zealand.
Trial summary
The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Danicopan, Midazolam and Fexofenadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNew Zealand
- Study dates
- 18 Apr 2017to 16 Jun 2017
- 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 60 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.
- Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.
Who cannot join
- Mentally or legally incapacitated or significant emotional problems.
- Any condition that might interfere with drug absorption.
- History of sensitivity to study medication or other drug allergies.
- Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
- Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
- Participated in another clinical study within 28 days prior to the first dose.
- Significant laboratory abnormalities.
- Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.
- Conditions
- Healthy
- Being tested
- Danicopan, Midazolam, Fexofenadine, Mycophenolate Mofetil
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Midazolam, Fexofenadine, Mycophenolate Mofetil, Drug Interaction, Pharmacokinetics, Factor D Inhibitor, Safety
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 (formerly)
Oral tablet.
MidazolamDrug
Also called Midazolam HCl
Oral syrup.
FexofenadineDrug
Oral tablet.
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Danicopan and Midazolam | Experimental | Period 1: Participants received a single dose of midazolam.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam.
Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. Receives: Drug: Danicopan; Drug: Midazolam |
| Part 2: Danicopan and Fexofenadine | Experimental | Period 1: Participants received a single dose of fexofenadine.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. Receives: Drug: Danicopan; Drug: Fexofenadine |
| Part 3: Danicopan and MMF | Experimental | Period 1: Participants received a single dose of MMF.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. Receives: Drug: Danicopan; Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 24 hours postdose
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 24 hours postdose
Part 1: Midazolam Maximum Observed Plasma Concentration (Cmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 24 hours postdose
Part 1: Midazolam Time To Reach Maximum Observed Plasma Concentration (Tmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 24 hours postdose
Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 3: Mycophenolic Acid (MPA) and Mycophenolic Acid Glucuronide (MPAG) AUC0-t Following Single-dose Mycophenolate Mofetil (MMF) Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 3: MPA and MPAG AUC0-inf Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Measured: Up to 72 hours postdose
Secondary outcomes (1)
Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events
Measured: 7 (±1) days following the last dose in Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start18 Apr 2017
- Primary completion2 Jun 2017
- Study completion16 Jun 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1, Part 2, and Part 3 could be conducted concurrently or separately, and the order of the parts could be determined according to the needs of the program.
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT03108274
- Sponsor's protocol ID
- ACH471-010
- Other IDs
- U1111-1193-2774
- Status last verified
- Jun 2021
- First submitted
- 28 Mar 2017
- Last updated
- 24 Jun 2021
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03108274
- Acronym / sponsor ID
- ACH471-010
- Conditions
- Healthy
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Midazolam, Fexofenadine, Mycophenolate Mofetil, Drug Interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 11 Apr 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 determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part 1, Part 2, and Part 3 could be conducted concurrently or separately, and the order of the parts could be determined according to the needs of the program.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Danicopan and Midazolam | Experimental | Drug: Danicopan, Drug: MidazolamPeriod 1: Participants received a single dose of midazolam. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam. Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
| Part 2: Danicopan and Fexofenadine | Experimental | Drug: Danicopan, Drug: FexofenadinePeriod 1: Participants received a single dose of fexofenadine. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine. Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
| Part 3: Danicopan and MMF | Experimental | Drug: Danicopan, Drug: Mycophenolate MofetilPeriod 1: Participants received a single dose of MMF. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF. Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
Who may qualify
- Ages
- 18 to 60 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.
- Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.
Key exclusion criteria (8 listed)
- Mentally or legally incapacitated or significant emotional problems.
- Any condition that might interfere with drug absorption.
- History of sensitivity to study medication or other drug allergies.
- Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
- Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of 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 |
|---|---|---|
| DanicopanAlso: ALXN2040, ACH-0144471 (formerly)Oral tablet. | Drug | Part 1: Danicopan and Midazolam, Part 2: Danicopan and Fexofenadine, Part 3: Danicopan and MMF |
| MidazolamAlso: Midazolam HClOral syrup. | Drug | Part 1: Danicopan and Midazolam |
| FexofenadineOral tablet. | Drug | Part 2: Danicopan and Fexofenadine |
| Mycophenolate MofetilOral tablet. | Drug | Part 3: Danicopan and MMF |
Primary outcome
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 24 hours postdose
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 24 hours postdose
Part 1: Midazolam Maximum Observed Plasma Concentration (Cmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 24 hours postdose
Part 1: Midazolam Time To Reach Maximum Observed Plasma Concentration (Tmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 24 hours postdose
Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 3: Mycophenolic Acid (MPA) and Mycophenolic Acid Glucuronide (MPAG) AUC0-t Following Single-dose Mycophenolate Mofetil (MMF) Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 3: MPA and MPAG AUC0-inf Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
Time frame: Up to 72 hours postdose
1 secondary outcome
Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events
Time frame: 7 (±1) days following the last dose in Period 2
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 24 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, Midazolam and Fexofenadine 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 8 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 24 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?
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan (time frame: Up to 24 hours postdose). The study lists 12 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 24 Jun 2021.