A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
NCT ID: NCT02963077
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2013-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1 SAD - 0.1 mg A4250
Dose: 0.1 mg of A4250. Sentinel dosing was used (2 sub-cohorts dosed a minimum of 24 h apart).
A4250
Cohort 2 SAD - 0.3 mg A4250
Dose: 0.3 mg of A4250.
A4250
Cohort 3 SAD - 1 mg A4250
Dose: 1 mg A4250.
A4250
Cohort 4 SAD - 3 mg A4250
Dose: 3 mg A4250.
A4250
Cohort 5 SAD - 10 mg A4250
Dose: 10 mg A4250.
A4250
Cohort 1 SAD placebo
Dose: 0.1 mg of A4250 matching placebo. Sentinel dosing was used (2 sub-cohorts dosed a minimum of 24 h apart).
Placebo
Cohort 2 SAD placebo
Dose: 0.3 mg A4250 matching placebo.
Placebo
Cohort 3 SAD placebo
Dose: 1 mg A4250 matching placebo.
Placebo
Cohort 4 SAD placebo
Dose: 3 mg A4250 matching placebo.
Placebo
Cohort 5 SAD placebo
Dose: 10 mg A4250 matching placebo.
Placebo
Cohort 1 MAD - 1 mg A4250 qd
Dose: 1 mg A4250 qd for 7 days.
A4250
Cohort 1 MAD placebo
Dose: 1 mg A4250 matching placebo qd for 7 days.
Placebo
Cohort 2 MAD - 3 mg A4250
Dose: 3 mg A4250 qd for 7 days
A4250
Cohort 2 MAD placebo
Dose: 3 mg A4250 matching placebo qd for 7 days.
Placebo
Cohort 3 MAD - 1.5 mg A4250 b.i.d for 7 days.
Dose: 1.5 mg A4250 b.i.d. for 7 days.
A4250
Cohort 3 MAD placebo
Dose: 1.5 A4250 matching placebo b.i.d for 7 days.
Placebo
Cohort 4 MAD - 3 mg A4250 qd + 1 mg Questran b.i.d
Dose: 3 mg A4250 qd + 1 mg Questran b.i.d for 7 days.
A4250
Questran
Cohort 4 MAD A4250 placebo + 1 mg Questran b.i.d
Dose: 3 mg A4250 matching placebo + 1 mg Questran b.i.d for 7 days.
Questran
Placebo
Cohort 5 MAD - 3 mg A4250 qd + 1 g CRC b.i.d
Dose: 3 mg A4250 qd + 1 g CRC b.i.d for 7 days.
A4250
CRC (A3384)
Cohort 5 MAD A4250 placebo + CRC placebo
Dose: 3 mg A4250 matching placebo qd + 1 g CRC placebo b.i.d for 7 days
Placebo
Cohort 6 MAD - 1 g CRC
Dose: 1 g CRC b.i.d
CRC (A3384)
Cohort 6 MAD CRC placebo
Dose: 1 g CRC matching placebo b.i.d.
Placebo
Cohort 7 MAD - 3 mg A4250 qd + 1 g CRC b.i.d
Dose: 3 mg A4250 qd + 1 g CRC b.i.d
A4250
CRC (A3384)
Cohort 7 MAD A4250 placebo + CRC placebo
Dose: 3 mg A4250 matching placebo qd + 1 g CRC matching placebo b.i.d.
Placebo
Interventions
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A4250
CRC (A3384)
Questran
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
Yes
Sponsors
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Albireo
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Other Identifiers
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2013-001175-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4250-001
Identifier Type: -
Identifier Source: org_study_id
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