HealthyPhase 1NCT05202145
Drug-Drug Interaction (DDI) Study of ALXN2050 in Healthy Adult Participants
A Phase 1 study testing ALXN2050, Cyclosporine and Tacrolimus in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3). 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, Cyclosporine and Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 21 Mar 2022
- 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
- Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee at Screening.
- Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter^2, inclusive, with a minimum body weight of 50.0 kg at Screening.
Who cannot join
- 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.
- Participation in another investigational drug or investigational device study within 5 half- lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco users or smokers or a positive cotinine test at Screening.
- Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2050 and Cyclosporine, Tacrolimus, and Mycophenolate Mofetil in Healthy Adult Participants
This study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).
- Conditions
- Healthy
- Being tested
- ALXN2050, Cyclosporine, Tacrolimus, MMF
- Keywords
- ALXN2050, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Drug-Drug Interaction, Pharmacokinetics, Safety, 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)
Oral tablet.
CyclosporineDrug
Oral capsule.
TacrolimusDrug
Oral capsule.
MMFDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Cyclosporine | Experimental | Participants will receive ALXN2050 and cyclosporine in a fixed sequence over 3 periods.
Period 1: Participants will receive multiple doses of ALXN2050.
Period 2: Participants will receive multiple doses of cyclosporine.
Period 3: Participants will receive multiple doses of ALXN2050 co-administered with multiple doses of cyclosporine.
There will be a washout period between the last dose of ALXN2050 in Period 1 and the first dose of cyclosporine in Period 2 and between the last dose of cyclosporine in Period 2 and the first dosing in Period 3. Receives: Drug: ALXN2050; Drug: Cyclosporine |
| Part 2 - Tacrolimus | Experimental | Participants will receive tacrolimus and ALXN2050 in a fixed sequence over 2 periods.
Period 1: Participants will receive a single dose of tacrolimus.
Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of tacrolimus.
There will be a washout period between the dose of tacrolimus in Period 1 and the first dose of ALXN2050 in Period 2. Receives: Drug: ALXN2050; Drug: Tacrolimus |
| Part 3 - MMF | Experimental | Participants will receive MMF and ALXN2050 in a fixed sequence over 2 periods.
Period 1: Participants will receive a single dose of MMF.
Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of MMF.
There will be a washout period between the dose of MMF in Period 1 and the first dose of ALXN2050 in Period 2. Receives: Drug: ALXN2050; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Cyclosporine: Area Under The Concentration-Time Curve From Time Zero To The 12-hour Time Point (AUC0-12) Following Multiple Dose Cyclosporine Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Part 1: ALXN2050 AUC0-12 Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Measured: Up to 72 hours postdose
Part 1: Cyclosporine Maximum Observed Concentration (Cmax) Following Multiple Dose Cyclosporine When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Part 1: ALXN2050 Cmax Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Measured: Up to 72 hours postdose
Part 1: Cyclosporine Time To Maximum Plasma Concentration (Tmax) Following Multiple Dose Cyclosporine When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Part 1: ALXN2050 Tmax Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Measured: Up to 72 hours postdose
Part 2: Tacrolimus Area Under The Concentration-Time Curve From Time Zero To The Last Observed Concentration (AUC0-t) Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 144 hours postdose
Part 2: Tacrolimus Area Under the Concentration-Time Curve From Time Zero To Infinity (AUC0-inf) Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence of Steady-state ALXN2050
Measured: Up to 144 hours postdose
Part 2: Tacrolimus Cmax Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 144 hours postdose
Part 2: Tacrolimus Tmax Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 144 hours postdose
Part 3: Mycophenolic Acid (MPA) And Mycophenolic Acid Glucuronide (MPAG) (Active Metabolites Of MMF) AUC0-t Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Part 3: MPA and MPAG AUC0-inf Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-State ALXN2050
Measured: Up to 72 hours postdose
Part 3: MPA And MPAG Cmax Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Part 3: MPA And MPAG Tmax Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Measured: Up to 72 hours postdose
Secondary outcomes (1)
Parts 1-3: Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through up to 12 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start11 Jan 2022
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
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
- This will be a 3-part study with each part being an open-label, fixed-sequence study in healthy adult participants. The 3 parts of the study may be conducted concurrently.
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT05202145
- Sponsor's protocol ID
- ALXN2050-HV-110
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2050 and Cyclosporine, Tacrolimus, and Mycophenolate Mofetil in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05202145
- Acronym / sponsor ID
- ALXN2050-HV-110
- Conditions
- Healthy
- Keywords
- ALXN2050, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Drug-Drug Interaction, Pharmacokinetics, Safety, Factor D Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 21 Jan 2022 (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 study will evaluate the potential drug interactions between ALXN2050 and cyclosporine (Part 1), between ALXN2050 and tacrolimus (Part 2), and between ALXN2050 and mycophenolate mofetil (MMF) (Part 3).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This will be a 3-part study with each part being an open-label, fixed-sequence study in healthy adult participants. The 3 parts of the study may be conducted concurrently.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Cyclosporine | Experimental | Drug: ALXN2050, Drug: CyclosporineParticipants will receive ALXN2050 and cyclosporine in a fixed sequence over 3 periods. Period 1: Participants will receive multiple doses of ALXN2050. Period 2: Participants will receive multiple doses of cyclosporine. Period 3: Participants will receive multiple doses of ALXN2050 co-administered with multiple doses of cyclosporine. There will be a washout period between the last dose of ALXN2050 in Period 1 and the first dose of cyclosporine in Period 2 and between the last dose of cyclosporine in Period 2 and the first dosing in Period 3. |
| Part 2 - Tacrolimus | Experimental | Drug: ALXN2050, Drug: TacrolimusParticipants will receive tacrolimus and ALXN2050 in a fixed sequence over 2 periods. Period 1: Participants will receive a single dose of tacrolimus. Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of tacrolimus. There will be a washout period between the dose of tacrolimus in Period 1 and the first dose of ALXN2050 in Period 2. |
| Part 3 - MMF | Experimental | Drug: ALXN2050, Drug: MMFParticipants will receive MMF and ALXN2050 in a fixed sequence over 2 periods. Period 1: Participants will receive a single dose of MMF. Period 2: Participants will receive multiple doses of ALXN2050 alone and co-administered with a single dose of MMF. There will be a washout period between the dose of MMF in Period 1 and the first dose of ALXN2050 in Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee at Screening.
- Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter^2, inclusive, with a minimum body weight of 50.0 kg at Screening.
Key exclusion criteria (4 listed)
- 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.
- Participation in another investigational drug or investigational device study within 5 half- lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco users or smokers or a positive cotinine test at Screening.
- Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
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)Oral tablet. | Drug | Part 1 - Cyclosporine, Part 2 - Tacrolimus, Part 3 - MMF |
| CyclosporineOral capsule. | Drug | Part 1 - Cyclosporine |
| TacrolimusOral capsule. | Drug | Part 2 - Tacrolimus |
| MMFOral tablet. | Drug | Part 3 - MMF |
Primary outcome
Part 1 Cyclosporine: Area Under The Concentration-Time Curve From Time Zero To The 12-hour Time Point (AUC0-12) Following Multiple Dose Cyclosporine Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
Part 1: ALXN2050 AUC0-12 Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Time frame: Up to 72 hours postdose
Part 1: Cyclosporine Maximum Observed Concentration (Cmax) Following Multiple Dose Cyclosporine When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
Part 1: ALXN2050 Cmax Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Time frame: Up to 72 hours postdose
Part 1: Cyclosporine Time To Maximum Plasma Concentration (Tmax) Following Multiple Dose Cyclosporine When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
Part 1: ALXN2050 Tmax Following Multiple Dose ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Cyclosporine
Time frame: Up to 72 hours postdose
Part 2: Tacrolimus Area Under The Concentration-Time Curve From Time Zero To The Last Observed Concentration (AUC0-t) Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 144 hours postdose
Part 2: Tacrolimus Area Under the Concentration-Time Curve From Time Zero To Infinity (AUC0-inf) Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence of Steady-state ALXN2050
Time frame: Up to 144 hours postdose
Part 2: Tacrolimus Cmax Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 144 hours postdose
Part 2: Tacrolimus Tmax Following Single Dose Tacrolimus When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 144 hours postdose
Part 3: Mycophenolic Acid (MPA) And Mycophenolic Acid Glucuronide (MPAG) (Active Metabolites Of MMF) AUC0-t Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
Part 3: MPA and MPAG AUC0-inf Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-State ALXN2050
Time frame: Up to 72 hours postdose
Part 3: MPA And MPAG Cmax Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
Part 3: MPA And MPAG Tmax Following Single Dose MMF When Dosed Alone Versus When Dosed In The Presence Of Steady-state ALXN2050
Time frame: Up to 72 hours postdose
1 secondary outcome
Parts 1-3: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through up to 12 days postdose
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 4 Apr 2023.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Cyclosporine and Tacrolimus 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 2 inclusion and 4 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 4 Apr 2023. 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. 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 Cyclosporine: Area Under The Concentration-Time Curve From Time Zero To The 12-hour Time Point (AUC0-12) Following Multiple Dose Cyclosporine Alone Versus When Dosed In The Presence Of Steady-state ALXN2050 (time frame: Up to 72 hours postdose). The study lists 14 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 4 Apr 2023.