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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C] NKTR-118

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348724

D3820C00001

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 1 patient group

[14C] NKTR-118

Experimental group

Treatment:

Drug: [14C] NKTR-118