Clinical trial NCT01975636: An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
Official title: An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Elimination
Keywords: Metabolism and Elimination
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 113
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single dose study in healthy male subjects.

Detailed description: A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.

On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:

* greater than 90% of the administered radioactivity has been recovered, and
* less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces

Eligibility criteria: Inclusion Criteria

Subjects must meet criteria to be included in this study, including but not limited to the following:

1. Healthy male 18 - 55 years, inclusive, at the time of informed consent
2. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
3. Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
4. Provide written informed consent
5. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

1. Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
2. Exposure to clinically significant radiation within 12 months prior to Day -2.
3. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
4. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
5. Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
6. Hypersensitivity to the study drugs or any of their excipients
7. Known to be human immunodeficiency virus (HIV) positive

Restrictions will apply on prior and concomitant medications, food and beverages

Primary outcomes:
measure: Pharmacokinetics: Elimination of E2609: urine/feces concentration
timeFrame: Predose and every 24 hours postdose up to 28 days
measure: Pharmacokinetics: Plasma concentration of E2609/metabolite
timeFrame: Predose andup to 648 hours postdose
Secondary outcomes:
measure: Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
timeFrame: Predose andup to 648 hours postdose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Inc.
state: Wisconsin
city: Madison
country: United States
facility: Covance Laboratories
state: Wisconsin
Study officials:
References: