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AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

Sponsor
Ardelyx (Industry)
Overall Status
Completed
CT.gov ID
NCT02063386
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
30
Duration (Days)
26.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD1722

Single oral dose 15 mg of [14C]AZD1722

Drug: AZD1722
Single oral dose 15 mg of [14C]AZD1722

Outcome Measures

Primary Outcome Measures

  1. Percentage of radioactive dose recovered in urine and feces [Day 1: Pre-dose and up to 168 hours post-dose]

  2. Total percentage of radioactive dose recovered from both urine and feces [Day 1: Pre-dose and up to 168 hours post-dose]

  3. Concentration of total radioactivity in blood and plasma samples [Timeframe: Day 1: Predose and up to 120 hours]

  4. Concentration of AZD1722 in plasma samples [Timeframe: Day 1: Predose and up to 120 hours]

Secondary Outcome Measures

  1. Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests) [up to 50 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site London United Kingdom

Sponsors and Collaborators

  • Ardelyx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ardelyx
ClinicalTrials.gov Identifier:
NCT02063386
Other Study ID Numbers:
  • D5611C00007
First Posted:
Feb 14, 2014
Last Update Posted:
Sep 22, 2015
Last Verified:
Sep 1, 2015

Study Results

No Results Posted as of Sep 22, 2015