Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C] NKTR-118

• Registration Number: NCT01348724
• Lead Sponsor: AstraZeneca

Brief Summary

Study to Assess the Absorption, Metabolism and Excretion of \[14C\] NKTR-118 after a Single-Dose Oral Administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Study Start: 2011-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg
• Regular daily bowel movements (ie, production of at least 1 stool per day).
• Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1

Exclusion Criteria

• Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
• Participation in any prior radiolabelled study within 12 months of screening visit 1
• Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
[14C] NKTR-118	[14C] NKTR-118	-

Primary Outcome Measures

Name	Time	Method
Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces	Range of Day 1 until day 10
Concentration of total radioactivity in blood and plasma samples	Range of Day 1 until day 10
Concentration of NKTR-118 in blood and plasma sample	Range of Day 1 until day 10

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples	Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event	Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs	Range of Day -1 until follow up visit (Visit 3)

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom