Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions

NCT03608319 | Completed Phase 1 FDA Drug

• 1 other identifier: A4250-004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Maximum observed plasma concentration (Cmax) of A4250 after a high fat meal

  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

  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

  prior to dosing through 18 hours post dose

• Maximum observed plasma concentration (Cmax) of A4250 sprinkled on applesauce

  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

  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

  prior to dosing through 18 hours post dose

Study Arms (3)

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

Interventions

A4250 DRUG

9.6 mg

Single dose following high fat breakfast; Single dose following overnight fast; Single dose sprinkled on applesauce following overnight fast

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albireo: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-Way Crossover Design

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 31, 2018
• Study Start: July 5, 2018
• Primary Completion: August 5, 2018
• Study Completion: August 18, 2018
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)