AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063386
• Other study ID #: D5611C00007
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2014
• Last updated: September 18, 2015
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: September 2015
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of radioactive dose recovered in urine and feces		Day 1: Pre-dose and up to 168 hours post-dose	No
Primary	Total percentage of radioactive dose recovered from both urine and feces		Day 1: Pre-dose and up to 168 hours post-dose	No
Primary	Concentration of total radioactivity in blood and plasma samples		Timeframe: Day 1: Predose and up to 120 hours	No
Primary	Concentration of AZD1722 in plasma samples		Timeframe: Day 1: Predose and up to 120 hours	No
Secondary	Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)		up to 50 days	Yes

External Links

•   CSR Synopsis