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A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects

NCT02963077•Albireo

View on ClinicalTrials.gov

Summary

The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In addition, will evaluate A4250 in combination with cholestyramine.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy males or non-pregnant, non-lactating healthy females
•2. BMI of 18 to 32 kg/m2 or, if outside the range, considered not clinically significant by the investigator
•3. Willing and able to communicate and participate in the whole study
•4. Provided written informed consent
•5. Agreed to use an adequate method of contraception

Exclusion Criteria

•1. Had participated in a clinical research study within the previous 3 months
•2. Were study site employees, or immediate family members of a study site or sponsor employee
•3. Had previously been enrolled in this study
•4. History of any drug or alcohol abuse in the past 2 years
•5. Regular alcohol consumption, in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
•6. Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening
•7. Females of childbearing potential who were pregnant or lactating (female subjects must have had a negative urine pregnancy test at admission)
•8. Did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
•9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
•10. Positive drugs of abuse test result
+7 more criteria

Key Dates

Start Date

July 1, 2013

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

March 7, 2024

Enrollment

ACTUAL participants

Conditions

Orphan Cholestatic Liver DiseasesPrimary Biliary CirrhosisProgressive Familial Intrahepatic CholestasisAlagille Syndrome

Interventions

A4250

DRUG

CRC (A3384)

DRUG

Questran

DRUG

Placebo

DRUG

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Progressive Familial Intrahepatic Cholestasis

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A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain

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PFIC - Progressive Familial Intrahepatic Cholestasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384

Inclusion Criteria

Exclusion Criteria

A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea

A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain

A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)

Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)

NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)