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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348724
• Other study ID #: D3820C00001
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2011
• Last updated: October 13, 2014
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C] NKTR-118
Single 25 mg oral dose administered on Day 1

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

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 samples and the total percentage of radioactive dose recovered in both urine and feces		Range of Day 1 until day 10	No
Primary	Concentration of total radioactivity in blood and plasma samples		Range of Day 1 until day 10	No
Primary	Concentration of NKTR-118 in blood and plasma sample		Range of Day 1 until day 10	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes

External Links

•   Clinical Study Report Synopsis