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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01348724

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C] NKTR-118	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male Volunteers

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C] NKTR-118	Drug: [14C] NKTR-118 Single 25 mg oral dose administered on Day 1

Arm

Intervention/Treatment

Experimental: [14C] NKTR-118

Drug: [14C] NKTR-118

Single 25 mg oral dose administered on Day 1

Outcome Measures

Primary Outcome Measures

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

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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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