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Trial record 11 of 14 for:    Alagille Syndrome

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

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ClinicalTrials.gov Identifier: NCT03082937
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Albireo

Brief Summary:
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in healthy male subjects.

Condition or disease Intervention/treatment Phase
Orphan Cholestatic Liver Diseases Progressive Familial Intrahepatic Cholestasis Alagille Syndrome Primary Biliary Cirrhosis Drug: 3 mg [14C]-A4250 capsule Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 8, 2017


Arm Intervention/treatment
Experimental: 3 mg [14C]-A4250 capsule Drug: 3 mg [14C]-A4250 capsule
Each subject will receive a single administration of 3 mg [14C]-A4250 capsule for oral administration containing not more than 4.3 MBq (116 μCi), in the fasted state.




Primary Outcome Measures :
  1. 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)) ]
    Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)

  2. 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)) ]
    Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)

  3. 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 ]
    Identification of the chemical structure of each metabolite accounting for greater than 10% of circulating radioactivity in plasma

  4. 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)) ]
    Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in urine

  5. 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)) ]
    Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in faeces



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082937


Locations
United Kingdom
Quotient Clinical
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Albireo
Investigators
Study Director: Mats Ekelund, MD Albireo

Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT03082937     History of Changes
Other Study ID Numbers: A4250-007
2016-002923-27 ( EudraCT Number )
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alagille Syndrome
Liver Diseases
Cholestasis
Liver Cirrhosis, Biliary
Cholestasis, Intrahepatic
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Liver Cirrhosis
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn