Healthy VolunteersPhase 1NCT03608319
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
A Phase 1 study testing A4250 in people with Healthy Volunteers, run by Albireo at 1 site in United States.
Trial summary
The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- A4250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 18 Aug 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study as self-reported.
- Body mass index (BMI) ≥ 18.0 and ≤ 28.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee at screening. Liver function (transaminases and serum bilirubin [total and direct]) must be within the upper limit of normal.
- Female subjects must be of non-childbearing potential: i.e. must be post-menopausal or have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
- bilateral tubal ligation or bilateral salpingectomy;
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- hysterectomy;
- bilateral oophorectomy;
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug.
- If male, must agree not to donate sperm from the first dose until 90 days after the last dose.
- Able to swallow multiple capsules.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- History or presence of malabsorption syndrome (including clinically significant loose stool or diarrhea, as deemed by the PI) or cholestasis.
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- Female subjects with a positive pregnancy test or lactating.
- Positive urine drug or alcohol results at screening or first check-in.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements (including fiber supplements and laxatives) beginning 14 days prior to the first dose and throughout the study.
- Is lactose intolerant.
- Donation of blood or significant blood loss within 56 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Participation in another clinical study within 30 days prior to the first dose. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Randomized, 3-Way Crossover Relative Bioavailability of A4250 in Healthy Adult Subjects Under Fasting and Fed Conditions and When Sprinkled on Applesauce
The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.
Read the detailed description
This is an open-label, randomized, 3-way crossover, food-effect and sprinkle study. On Day 1 of each period, subjects will receive a single oral dose of A4250 under 1 of 3 conditions: fasting, following a high-fat, high-calorie breakfast, or sprinkled on applesauce. Subjects will receive A4250 under each condition on one occasion. Blood samples for PK analysis will be collected for 18 hours following each study drug administration. There will be a washout period of at least 7 days between doses. Study participants will be contacted approximately 14 days after the last study drug administration to determine if any adverse event (AE) has occurred since the last study visit.
- Conditions
- Healthy Volunteers
- Being tested
- A4250
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A4250Drug
9.6 mg
| Study group | Role | What they receive |
|---|---|---|
| Single dose following overnight fast | Experimental | Not described Receives: Drug: A4250 |
| Single dose following high fat breakfast | Experimental | Not described Receives: Drug: A4250 |
| Single dose sprinkled on applesauce following overnight fast | Experimental | Not described Receives: Drug: A4250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of A4250 after a high fat meal
Measured: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinity (AUC (0-inf)) of A4250 after a high fat meal
Measured: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero to last measurable concentration (AUC(0-t)) of A4250 after a high fat meal
Measured: prior to dosing through 18 hours post dose
Maximum observed plasma concentration (Cmax) of A4250 sprinkled on applesauce
Measured: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinity (AUC (0-inf)) of A4250 sprinkled on applesauce
Measured: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero to last measurable concentration (AUC(0-t)) of A4250 sprinkled on applesauce
Measured: prior to dosing through 18 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start5 Jul 2018
- Primary completion5 Aug 2018
- Study completion18 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- 3-Way Crossover Design
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albireo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608319
- Sponsor's protocol ID
- A4250-004
- Status last verified
- Mar 2024
- First submitted
- 13 Jul 2018
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, 3-Way Crossover Relative Bioavailability of A4250 in Healthy Adult Subjects Under Fasting and Fed Conditions and When Sprinkled on Applesauce
- ClinicalTrials.gov ID
- NCT03608319
- Acronym / sponsor ID
- A4250-004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AlbireoIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 18 Aug 2018 (actual)
- First posted
- 31 Jul 2018 (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 objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.
Detailed description
This is an open-label, randomized, 3-way crossover, food-effect and sprinkle study. On Day 1 of each period, subjects will receive a single oral dose of A4250 under 1 of 3 conditions: fasting, following a high-fat, high-calorie breakfast, or sprinkled on applesauce. Subjects will receive A4250 under each condition on one occasion. Blood samples for PK analysis will be collected for 18 hours following each study drug administration. There will be a washout period of at least 7 days between doses. Study participants will be contacted approximately 14 days after the last study drug administration to determine if any adverse event (AE) has occurred since the last study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-Way Crossover Design
| Arm | Type | Receives |
|---|---|---|
| Single dose following overnight fast | Experimental | Drug: A4250 |
| Single dose following high fat breakfast | Experimental | Drug: A4250 |
| Single dose sprinkled on applesauce following overnight fast | Experimental | Drug: A4250 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study as self-reported.
- Body mass index (BMI) ≥ 18.0 and ≤ 28.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee at screening. Liver function (transaminases and serum bilirubin [total and direct]) must be within the upper limit of normal.
- Female subjects must be of non-childbearing potential: i.e. must be post-menopausal or have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
Key exclusion criteria (15 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
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 |
|---|---|---|
| A42509.6 mg | Drug | Single dose following high fat breakfast, Single dose following overnight fast, Single dose sprinkled on applesauce following overnight fast |
Primary outcome
Maximum observed plasma concentration (Cmax) of A4250 after a high fat meal
Time frame: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinity (AUC (0-inf)) of A4250 after a high fat meal
Time frame: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero to last measurable concentration (AUC(0-t)) of A4250 after a high fat meal
Time frame: prior to dosing through 18 hours post dose
Maximum observed plasma concentration (Cmax) of A4250 sprinkled on applesauce
Time frame: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinity (AUC (0-inf)) of A4250 sprinkled on applesauce
Time frame: prior to dosing through 18 hours post dose
Area under the plasma concentration time curve from time zero to last measurable concentration (AUC(0-t)) of A4250 sprinkled on applesauce
Time frame: prior to dosing through 18 hours post dose
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 7 Mar 2024.
- 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.
Ipsen Medical Director study director
Ipsen
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 A4250 in people with Healthy Volunteers, run by Albireo 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 12 inclusion and 15 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 7 Mar 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 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?
Maximum observed plasma concentration (Cmax) of A4250 after a high fat meal (time frame: prior to dosing through 18 hours post dose). The study lists 6 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 7 Mar 2024.