An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03082937
• Date of registration: 27/02/2017
• Prospective Registration: No
• Primary sponsor: Albireo
• Public title: An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
• Scientific title: An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects
• Date of first enrolment: January 31, 2017
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03082937
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy males

2. Age 30 to 65 years of age

3. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not
clinically significant by the investigator

4. Must be willing and able to communicate and participate in the whole study

5. Must have regular bowel movements (i.e., average stool production of =1 and =3 stools
per day)

6. Must provide written informed consent

7. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous 3
months prior to screening

2. Subjects who are study site employees, or immediate family members of a study site or
sponsor employee

3. Subjects who have 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 (1 unit = ½ pint beer, 25 mL
of 40% spirit or a 125 mL glass of wine)

6. Current smokers and those who have smoked within the last 12 months. A confirmed
positive urine cotinine test at screening or admission

7. Current users of e-cigarettes and nicotine replacement products and those who have
used these products within the last 12 months

8. Radiation exposure, including that from the present study, excluding background
radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv
in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
as defined in the Ionising Radiation Regulations 1999, shall participate in the study

9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as
assessed by the investigator at screening

10. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by
the investigator

11. Confirmed positive drugs of abuse test result at screening or admission

12. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results

13. Evidence of renal impairment at screening, as indicated by an estimated creatinine
clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation

14. History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged
by the investigator

15. Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients

16. Presence or history of clinically significant allergy requiring treatment, as judged
by the investigator. Hayfever is allowed unless it is active

17. Donation or loss of greater than 400 mL of blood within the previous 3 months

18. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other
than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP
administration. Exceptions may apply on a case by case basis, if considered not to
interfere with the objectives of the study, as agreed by the PI and sponsor's medical
monitor.

19. Failure to satisfy the investigator of fitness to participate for any other reason



Age minimum: 30 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Orphan Cholestatic Liver Diseases

Alagille Syndrome

Primary Biliary Cirrhosis

Progressive Familial Intrahepatic Cholestasis

Intervention(s)

Drug: 3 mg [14C]-A4250 capsule

Primary Outcome(s)

To assess mass balance recovery of total radioactivity in faeces [Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))]

Metabolite profiling of A4250 of plasma using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate [Time Frame: Between pre-dose and up to 48 hours post dose]

Metabolite profiling of A4250 of faeces using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate [Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))]

To assess mass balance recovery of total radioactivity in urine [Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))]

Metabolite profiling of A4250 of urine using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate [Time Frame: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))]

Secondary ID(s)

2016-002923-27

A4250-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors