AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

NCT02063386 | Completed Phase 1

• 1 other identifier: D5611C00007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Percentage of radioactive dose recovered in urine and feces

  Day 1: Pre-dose and up to 168 hours post-dose

• Total percentage of radioactive dose recovered from both urine and feces

  Day 1: Pre-dose and up to 168 hours post-dose

• Concentration of total radioactivity in blood and plasma samples

  Timeframe: Day 1: Predose and up to 120 hours

• Concentration of AZD1722 in plasma samples

  Timeframe: Day 1: Predose and up to 120 hours

Secondary Outcomes (1)

• Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)

  up to 50 days

Study Arms (1)

AZD1722

EXPERIMENTAL

Single oral dose 15 mg of \[14C\]AZD1722

Drug: AZD1722

Interventions

AZD1722 DRUG

Single oral dose 15 mg of \[14C\]AZD1722

AZD1722

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Interventions

tenapanor

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 14, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

GB (1)