Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

Conditions

Healthy Volunteers

Keywords

Radiolabelled, AME

Brief summary

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Related papers

No related papers found yet.

Interventions

DRUGRadiolabeled SPD557

A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Males ages 18 to 50 years * Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2 * Subject is willing to comply with any applicable contraceptive and sperm donation requirements Key

Exclusion criteria

* Have participated in a \[14C\]-study within the last 6 months. * Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring). * Male subjects who consume more than 21 units of alcohol per week or 3 units per day. * Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358	Over 240 hours post-dose	Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358	Over 240 hours post-dose	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358	Over 240 hours post-dose	—
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358	Over 240 hours post-dose	—
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358	Over 240 hours post-dose	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Radiolabelled SSP-002358 A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1	6
Total	6

Baseline characteristics

Characteristic	Radiolabelled SSP-002358
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	6 Participants
Age, Continuous	29.5 Years STANDARD_DEVIATION 2.07
Region of Enrollment UNITED STATES	6 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 6
serious Total, serious adverse events	0 / 6

Outcome results

Primary

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358

Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.