AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

Ardelyx

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: AZD1722

Study type

Interventional

Funder types

Industry

Identifiers

NCT02063386

D5611C00007

Details and patient eligibility

About

To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.

Enrollment

26 patients

Sex

Male

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers aged ≥50 years
Regular daily bowel movements.
Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.

Exclusion criteria

History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
Volunteers exposed to radiation levels above background (eg, via X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life.
Participation in a previously radiolabelled study within the last 5 years