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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02963077
Other study ID # A4250-001
Secondary ID 2013-001175-21
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2013
Est. completion date May 2014

Study information

Verified date March 2024
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 11. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 12. History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator 13. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients eg lactose or contraindications to cholestyramine/Questran 14. Presence or history of clinically significant allergy requiring treatment as per the judgement of the investigator Hayfever was allowed unless it was active 15. Donation or loss of greater than 400 mL of blood within the previous 3 months 16. Were taking, or had taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol, hormone replacement therapy [HRT] and hormonal contraception) or herbal remedies in the 14 days before IMP administration unless they were not considered to have interfered with the objectives of the study, as agreed by the PI and sponsor's medical monitor on a case by case basis 17. Failed to satisfy the investigator of fitness to participate for any other reason

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
A4250

CRC (A3384)

Questran

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Albireo

Outcome

Type Measure Description Time frame Safety issue
Primary Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following A Single Oral 10 mg A4250 Dose - Tmax Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Primary Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - Cmax Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Primary Mean (± SD) Plasma Pharmacokinetic Concentrations of A4250 Following a Single Oral 10 mg A4250 Dose - AUC 0-t Pharmacokinetic blood samples were taken pre-dose, and post-dose at: 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
Primary Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 4 h Post-Dose Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Primary Mean (SD) Change in FGF19 from Day 1 Pre-Dose to 24 h Post-Dose Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Primary Mean (SD) Change in C4 from Day 1 Pre-Dose to 4 h Post-Dose Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Primary Mean (SD) Change in C4 from Day 1 Pre-Dose to 24 h Post-Dose Pharmacodynamic blood samples were taken pre-dose and at 4 hours and 24 hours post-dosing, and at follow-up (5-7 days after final dose).
Primary Mean (SD) Changes in Total Bile Acids for A4250 4 h compared to pre-dose Samples were taken pre-dose and post-dose at 4 hours and 24 hours.
Primary Mean (SD) Changes in Total Bile Acids for A4250 24 h compared to pre-dose Samples were taken pre-dose, and post-dose at 4 hours and 24 hours.
Primary Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma FGF19 AUC(0-12) on Day 7 (only for Part II)
Primary Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma C4 AUC(0-12) on Day 7 (only Part II)
Primary Geometric (geometric CV%) Mean for AUC(0-12) on Day 7 for plasma Total Bile Acids AUC(0-12) on Day 7 (only Part II)
Primary Mean (SD) Changes in Faecel Total Bile Acids from Day 1 Pre-Dose on Day 7 at 24 h Post-dose Change from Day 1 Pre-dose to Day 7 at 24 hours Post-dose
Primary Mean (SD) Change in Faecal Total Bile Acids Excreted (ng) from Day 1 Pre-Dose on Day 7 Post-Dose Change from Day 1 Pre-dose to Day 7 at 24 hours Post-dose
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