HealthyPhase 1NCT04660890
A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
A Phase 1 study testing ALXN2050 and Moxifloxacin in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 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?
- ALXN2050 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2020to 16 Mar 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 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 50.0 kg at screening.
- No clinically significant history or presence of ECG abnormalities at screening.
- Female participants must be of non-childbearing potential and need not employ a method of contraception.
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
Who cannot join
- Clinically significant laboratory abnormalities.
- 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 and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.
- History or presence of clinically significant seizures, head injury, or head trauma.
- History of procedures that could alter absorption or excretion of orally administered drugs.
- History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
Show all 10Show fewer
- 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°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.
- Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months 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 is longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
Read the detailed description
Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.
- Conditions
- Healthy
- Being tested
- ALXN2050, ALXN2050-matching Placebo, Moxifloxacin, Moxifloxacin-matching Placebo
- Keywords
- ALXN2050, Electrocardiogram, QT Interval, Concentration-QT, Factor D Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2050Drug
Also called ACH-0145228 (formerly)
ALXN2050 will be administered orally twice daily as powder-in-capsule.
ALXN2050-matching PlaceboDrug
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
MoxifloxacinDrug
Moxifloxacin will be administered as a single oral dose.
Moxifloxacin-matching PlaceboDrug
Moxifloxacin-matching placebo will be administered as a single oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (ABC) | Experimental | Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods:
Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo.
Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo.
Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo. Receives: Drug: ALXN2050; Drug: Moxifloxacin-matching Placebo |
| Control Arm (DEF) | Placebo comparator | Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin.
Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Receives: Drug: ALXN2050-matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin-matching Placebo |
| Control Arm (GHI) | Placebo comparator | Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin.
Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin. Receives: Drug: ALXN2050-matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin-matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050
Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.
Measured: Pre-dose through 24 hours post-dose
Secondary outcomes (6)
Change From Baseline PR Interval (dPR) For ALXN2050
Twelve-lead ECGs will be extracted from continuous (Holter) recordings.
Measured: Pre-dose through 24 hours post-dose
ddQTc For Moxifloxacin
Twelve-lead ECGs will be extracted from continuous (Holter) recordings.
Measured: Pre-dose through 24 hours post-dose
Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050
Measured: Pre-dose through 24 hours post-dose
Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050
Measured: Up to 24 hours postdose
Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050
Measured: Pre-dose through 24 hours post-dose
Incidence Of Treatment-emergent Adverse Events
Measured: Day 1 (postdose) through follow-up (7 [+/- 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 posted9 Dec 2020
- Study start12 Dec 2020
- Primary completion16 Mar 2021
- Study completion16 Mar 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 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
- NCT04660890
- Sponsor's protocol ID
- ALXN2050-HV-107
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2020
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04660890
- Acronym / sponsor ID
- ALXN2050-HV-107
- Conditions
- Healthy
- Keywords
- ALXN2050, Electrocardiogram, QT Interval, Concentration-QT, Factor D Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 9 Dec 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 randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
Detailed description
Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (ABC) | Experimental | Drug: ALXN2050, Drug: Moxifloxacin-matching PlaceboTreatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods: Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo. Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo. Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo. |
| Control Arm (DEF) | Placebo comparator | Drug: ALXN2050-matching Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin-matching PlaceboTreatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin. Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. |
| Control Arm (GHI) | Placebo comparator | Drug: ALXN2050-matching Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin-matching PlaceboTreatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin. Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin. |
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 50.0 kg at screening.
- No clinically significant history or presence of ECG abnormalities at screening.
- Female participants must be of non-childbearing potential and need not employ a method of contraception.
- Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
Key exclusion criteria (10 listed)
- Clinically significant laboratory abnormalities.
- 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 and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.
- History or presence of clinically significant seizures, head injury, or head trauma.
- History of procedures that could alter absorption or excretion of orally administered 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 |
|---|---|---|
| ALXN2050Also: ACH-0145228 (formerly)ALXN2050 will be administered orally twice daily as powder-in-capsule. | Drug | Treatment Arm (ABC) |
| ALXN2050-matching PlaceboALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule. | Drug | Control Arm (DEF), Control Arm (GHI) |
| MoxifloxacinMoxifloxacin will be administered as a single oral dose. | Drug | Control Arm (DEF), Control Arm (GHI) |
| Moxifloxacin-matching PlaceboMoxifloxacin-matching placebo will be administered as a single oral dose. | Drug | Control Arm (DEF), Control Arm (GHI), Treatment Arm (ABC) |
Primary outcome
Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050
Time frame: Pre-dose through 24 hours post-dose
Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.
6 secondary outcomes
Change From Baseline PR Interval (dPR) For ALXN2050
Time frame: Pre-dose through 24 hours post-dose
ddQTc For Moxifloxacin
Time frame: Pre-dose through 24 hours post-dose
Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050
Time frame: Pre-dose through 24 hours post-dose
Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050
Time frame: Up to 24 hours postdose
Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050
Time frame: Pre-dose through 24 hours post-dose
Incidence Of Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (7 [+/- 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 29 Dec 2021.
- 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 ALXN2050 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 10 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 29 Dec 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 QTc Intervals (ddQTc) For ALXN2050 (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 29 Dec 2021.