- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03608319
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Celerion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single dose following overnight fast
|
9.6 mg
|
Experimental: Single dose following high fat breakfast
|
9.6 mg
|
Experimental: Single dose sprinkled on applesauce following overnight fast
|
9.6 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax) of A4250 after a high fat meal
Time Frame: prior to dosing through 18 hours post dose
|
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
|
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
|
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
|
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
|
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
|
prior to dosing through 18 hours post dose
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A4250-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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