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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01348724

Enrollment

Registered

2011-05-05

Start date

2011-06-30

Completion date

2011-09-30

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers

Brief summary

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

Interventions

DRUG[14C] NKTR-118

Single 25 mg oral dose administered on Day 1

Study design

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026