Overview

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

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Albireo
Treatments:
Cholestyramine Resin
Criteria
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