HealthyPhase 1NCT05016206
A Study of the Cardiac Effects of Danicopan in Healthy Adults
A Phase 1 study testing Danicopan and Moxifloxacin in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval 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 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 12 Oct 2018
- 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
- Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50 kg at screening.
- Female participants must have been of nonchildbearing potential.
- Nonsterile male participants must have agreed to abstinence or used a highly effective method of contraception.
- No clinically significant history or presence of electrocardiogram findings at screening and check-in.
Who cannot join
- Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.
- 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 2 years prior to first dosing; current tobacco/nicotine user or a positive cotinine test at screening; positive for alcohol and/or drugs-of-abuse screen at screening or first check-in.
- Any previous procedure that could alter absorption or excretion of orally administered drugs.
- A history of significant multiple and/or severe allergies or had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- Body temperature ≥ 38°Celsius on Day -2 or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.
- 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 was longer.
- Donation of whole blood from 3 months before first dosing, or of plasma from 30 days before first dosing; received blood products within 6 months before first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive Controlled Study to Evaluate the Effect of ACH-0144471 on the QT Interval in Healthy Adult Subjects
This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval in healthy adult participants.
Read the detailed description
Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan was administered with a moxifloxacin-matching placebo on Day 1 of each period.
Participants randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching placebo, as per the assigned randomization scheme, on Day 1 of each period.
- Conditions
- Healthy
- Being tested
- Danicopan, Moxifloxacin-matching Placebo, Danicopan-matching placebo, Moxifloxacin
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Electrocardiogram, QT Interval, Concentration-QT
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), ACH-4471, ACH4471
Danicopan tablets administered as a single oral dose.
Moxifloxacin-matching PlaceboDrug
Moxifloxacin-matching placebo was administered as a single oral dose.
Danicopan-matching placeboDrug
Danicopan-matching placebo was administered as a single oral dose.
MoxifloxacinDrug
Also called Avelox
Moxifloxacin 400 mg was administered as a single tablet oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (ABC) | Experimental | Treatment Sequence ABC - Participants received all 3 doses of danicopan in ascending fashion over 3 periods:
Treatment A (Period 1): Danicopan 400 milligrams (mg) and moxifloxacin-matching placebo.
Treatment B (Period 2): Danicopan 800 mg and moxifloxacin-matching placebo.
Treatment C (Period 3): Danicopan 1200 mg and moxifloxacin-matching placebo. Receives: Drug: Danicopan; Drug: Moxifloxacin-matching Placebo |
| Control Arm (EFG and IJK) | Placebo comparator | Participants received 1 of 2 treatment sequences (Treatment Sequence EFG or Treatment Sequence IJK) over 3 periods:
Treatment E (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin-matching placebo.
Treatment F (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin 400 mg.
Treatment G (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin-matching placebo.
Treatment I (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin 400 mg.
Treatment J (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin-matching placebo.
Treatment K (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin 400 mg. Receives: Drug: Moxifloxacin-matching Placebo; Drug: Danicopan-matching placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan
Measured: Pre-dose through 24 hours post-dose
Secondary outcomes (11)
Change From Baseline In Heart Rate (HR) For Danicopan
Measured: Pre-dose through 24 hours post-dose
Change From Baseline In QT Interval For Danicopan
Measured: Pre-dose through 24 hours post-dose
Change From Baseline In Pulse Rate (PR) For Danicopan
Measured: Pre-dose through 24 hours post-dose
Change From Baseline In RR Interval For Danicopan
Measured: Pre-dose through 24 hours post-dose
Change From Baseline In QRS Interval For Danicopan
Measured: Pre-dose through 24 hours post-dose
ddQTcF Of Moxifloxacin
Measured: Pre-dose through 24 hours post-dose
Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves
Measured: Pre-dose through 24 hours post-dose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan
Measured: Pre-dose through 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) Of Danicopan
Measured: Pre-dose through 24 hours post-dose
Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan
Measured: Pre-dose through 24 hours post-dose
Number Of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up visit (14 [+/- 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 posted23 Aug 2021
- Study start26 Jul 2018
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
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
- Parallel groups
- Model description
- This was a double-dummy, placebo- and positive-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT05016206
- Sponsor's protocol ID
- ACH471-013
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive Controlled Study to Evaluate the Effect of ACH-0144471 on the QT Interval in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05016206
- Acronym / sponsor ID
- ACH471-013
- Conditions
- Healthy
- Keywords
- Danicopan, ALXN2040, ACH-0144471, Electrocardiogram, QT Interval, Concentration-QT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 23 Aug 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, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval in healthy adult participants.
Detailed description
Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan was administered with a moxifloxacin-matching placebo on Day 1 of each period.
Participants randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching placebo, as per the assigned randomization scheme, on Day 1 of each period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a double-dummy, placebo- and positive-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (ABC) | Experimental | Drug: Danicopan, Drug: Moxifloxacin-matching PlaceboTreatment Sequence ABC - Participants received all 3 doses of danicopan in ascending fashion over 3 periods: Treatment A (Period 1): Danicopan 400 milligrams (mg) and moxifloxacin-matching placebo. Treatment B (Period 2): Danicopan 800 mg and moxifloxacin-matching placebo. Treatment C (Period 3): Danicopan 1200 mg and moxifloxacin-matching placebo. |
| Control Arm (EFG and IJK) | Placebo comparator | Drug: Moxifloxacin-matching Placebo, Drug: Danicopan-matching placebo, Drug: MoxifloxacinParticipants received 1 of 2 treatment sequences (Treatment Sequence EFG or Treatment Sequence IJK) over 3 periods: Treatment E (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin-matching placebo. Treatment F (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin 400 mg. Treatment G (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin-matching placebo. Treatment I (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin 400 mg. Treatment J (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin-matching placebo. Treatment K (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin 400 mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50 kg at screening.
- Female participants must have been of nonchildbearing potential.
- Nonsterile male participants must have agreed to abstinence or used a highly effective method of contraception.
- No clinically significant history or presence of electrocardiogram findings at screening and check-in.
Key exclusion criteria (8 listed)
- Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.
- 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 2 years prior to first dosing; current tobacco/nicotine user or a positive cotinine test at screening; positive for alcohol and/or drugs-of-abuse screen at screening or first check-in.
- Any previous procedure that could alter absorption or excretion of orally administered drugs.
- A history of significant multiple and/or severe allergies or 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 |
|---|---|---|
| DanicopanAlso: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471Danicopan tablets administered as a single oral dose. | Drug | Treatment Arm (ABC) |
| Moxifloxacin-matching PlaceboMoxifloxacin-matching placebo was administered as a single oral dose. | Drug | Control Arm (EFG and IJK), Treatment Arm (ABC) |
| Danicopan-matching placeboDanicopan-matching placebo was administered as a single oral dose. | Drug | Control Arm (EFG and IJK) |
| MoxifloxacinAlso: AveloxMoxifloxacin 400 mg was administered as a single tablet oral dose. | Drug | Control Arm (EFG and IJK) |
Primary outcome
Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
11 secondary outcomes
Change From Baseline In Heart Rate (HR) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In QT Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In Pulse Rate (PR) For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In RR Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
Change From Baseline In QRS Interval For Danicopan
Time frame: Pre-dose through 24 hours post-dose
ddQTcF Of Moxifloxacin
Time frame: Pre-dose through 24 hours post-dose
Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves
Time frame: Pre-dose through 24 hours post-dose
Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan
Time frame: Pre-dose through 24 hours post-dose
Number Of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up visit (14 [+/- 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 23 Aug 2021.
- Individual participant dataSharing planned: Yes
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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 and Moxifloxacin 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 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 23 Aug 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 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. Some participants in this study may receive a placebo. 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?
Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan (time frame: Pre-dose through 24 hours post-dose). 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 23 Aug 2021.