Healthy ParticipantsPhase 1NCT05780645
A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
A Phase 1 study testing ALXN2050 MR Prototype Tablet, ALXN2050 Immediate Release (IR) Tablet and ALXN2050 MR Prototype Mini-Tablet in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ALXN2050 MR Prototype Tablet, ALXN2050 Immediate Release (IR) Tablet and ALXN2050 MR Prototype Mini-Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2023to 26 Feb 2024
- 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 males or non-pregnant, non-lactating healthy females.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- BMI within the range of 18.0 to 30.0 kg/m2 (inclusive), with a minimum body weight of 50.0 kg at screening.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
Who cannot join
- History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, hematological, psychological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of meningococcal infection.
- History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- History of significant multiple and/or severe allergies (eg, drug, latex allergy, band aids, adhesive dressing, or medical tape). Hay fever is allowed unless it is active.
- History of seizures including childhood seizures.
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- History of significant head injury, or head trauma requiring medical evaluation.
- History of malignancy within 5 years of screening, with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Any previous procedure, including history of stomach or intestinal surgery or resection, cholecystectomy, gallstones, TIPS, or surgical shunt, that could alter absorption or excretion of orally administered drugs.
- Significant current or chronic history of liver disease.
- Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Phase 1 Study to Evaluate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
The primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.
- Conditions
- Healthy Participants
- Being tested
- ALXN2050 MR Prototype Tablet, ALXN2050 Immediate Release (IR) Tablet, ALXN2050 MR Prototype Mini-Tablet
- Keywords
- Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2050 MR Prototype TabletDrug
Participants will receive various doses of the MR Prototype Tablet orally.
ALXN2050 Immediate Release (IR) TabletDrug
Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
ALXN2050 MR Prototype Mini-TabletDrug
Participants will receive various doses of the MR Prototype Mini-Tablet orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Regimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions.
Optional Regimens C, D, E, and F Receives: Drug: ALXN2050 MR Prototype Tablet; Drug: ALXN2050 Immediate Release (IR) Tablet |
| Cohort 2 | Experimental | Regimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions.
Optional Regimens: I, J, K, and L Receives: Drug: ALXN2050 Immediate Release (IR) Tablet; Drug: ALXN2050 MR Prototype Mini-Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Measured: Up to 96 hours postdose
Time to Reach Cmax (Tmax) of ALXN2050
Measured: Up to 96 hours postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
Measured: Up to 96 hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
Measured: Day 1 up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Mar 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780645
- Sponsor's protocol ID
- D7841C00008
- Status last verified
- Jun 2024
- First submitted
- 13 Mar 2023
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Phase 1 Study to Evaluate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05780645
- Acronym / sponsor ID
- D7841C00008
- Conditions
- Healthy Participants
- Keywords
- Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 22 Mar 2023 (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 primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ALXN2050 MR Prototype Tablet, Drug: ALXN2050 Immediate Release (IR) TabletRegimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions. Optional Regimens C, D, E, and F |
| Cohort 2 | Experimental | Drug: ALXN2050 Immediate Release (IR) Tablet, Drug: ALXN2050 MR Prototype Mini-TabletRegimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions. Optional Regimens: I, J, K, and L |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or non-pregnant, non-lactating healthy females.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
- BMI within the range of 18.0 to 30.0 kg/m2 (inclusive), with a minimum body weight of 50.0 kg at screening.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
Key exclusion criteria (11 listed)
- History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, hematological, psychological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of meningococcal infection.
- History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- History of significant multiple and/or severe allergies (eg, drug, latex allergy, band aids, adhesive dressing, or medical tape). Hay fever is allowed unless it is active.
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 |
|---|---|---|
| ALXN2050 MR Prototype TabletParticipants will receive various doses of the MR Prototype Tablet orally. | Drug | Cohort 1 |
| ALXN2050 Immediate Release (IR) TabletParticipants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally. | Drug | Cohort 1, Cohort 2 |
| ALXN2050 MR Prototype Mini-TabletParticipants will receive various doses of the MR Prototype Mini-Tablet orally. | Drug | Cohort 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Time frame: Up to 96 hours postdose
Time to Reach Cmax (Tmax) of ALXN2050
Time frame: Up to 96 hours postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
Time frame: Up to 96 hours postdose
1 secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Day 1 up to Day 15
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 6 Jun 2024.
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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 MR Prototype Tablet, ALXN2050 Immediate Release (IR) Tablet and ALXN2050 MR Prototype Mini-Tablet in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
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 11 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 6 Jun 2024. 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 Kingdom. 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?
Maximum Observed Plasma Concentration (Cmax) of ALXN2050 (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 6 Jun 2024.