Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function

A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (SPD602) in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732263

Enrollment

Registered

2012-11-22

Start date

2012-11-09

Completion date

2013-04-01

Last updated

2021-07-19

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

Conditions

Healthy, Hepatic Impairment

Brief summary

The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.

Interventions

DRUGSSP-004184

All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18-65 years inclusive at the time of consent. * Willingness to comply with any applicable contraceptive requirements of the protocol and is: * Male, or * Non pregnant, non lactating female * Females must be at least 90 days post partum or nulliparous. Subjects who do not have hepatic impairment (healthy subjects) * Normal renal function. Subjects with hepatic impairment * Subjects must provide a letter of evaluation from a hepatologist or copy of supporting documents confirming the subject's hepatic impairment (a liver biopsy is preferable but not mandatory). * Hepatic impairment should be primary and must not be a complication of an underlying primary systemic disease (eg, patients with metastatic cancer and cancer cachexia) * Documented chronic stable liver impairment

Exclusion criteria

Subjects who do not have hepatic impairment (healthy subjects) * A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen. Subjects with hepatic impairment * Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an infection or drug toxicity. * Presence of surgically created or transjugular intrahepatic portal systemic shunts. * A positive HIV antibody screen. * Renal insufficiency. All subjects * Subject has a history of thyroid disorder. * History of nephrotic syndrome. * History of alcohol or other substance abuse within the last year. * A positive screen for alcohol or drugs of abuse. * Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer \[12 oz/355 mL\] = 1 wine \[5 oz/150 mL\] = 1 liquor \[1.5 oz/40 mL\] = 0.75 oz/20 mL alcohol.) * Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3 oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain caffeine.) * Donation of blood or blood products within 60 days. * Substantial changes in eating habits within 30 days.

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184	Over 96 hours post-dose	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 SSP-004184	Over 96 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 administrated.
Time of Maximum Plasma Concentration (Tmax) for SSP-004184	Over 96 hours post-dose	Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Plasma Half-Life (T 1/2) of SSP-004184	Over 96 hours post-dose	The time it takes for the blood plasma concentration of a substance to halve.
Total Body Clearance (CL/F) of SSP-004184	Over 96 hours post-dose	The rate at which a drug is removed from the body.
Volume of Distribution (Vz/F) of SSP-004184	Over 96 hours post-dose	The distribution of a medication between plasma and the rest of the body.

Countries

United States

Participant flow

Pre-assignment details

One subject withdrew from study prior to randomization (n = 43).

Participants by arm

Arm	Count
Hepatic Impairment All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).	23
Matched Healthy Subjects All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).	20
Total	43

Baseline characteristics

Characteristic	Hepatic Impairment	Matched Healthy Subjects	Total
Age, Continuous	56.3 Years STANDARD_DEVIATION 5.13	55.1 Years STANDARD_DEVIATION 5.51	55.7 Years STANDARD_DEVIATION 5.28
Age, Customized >=65 years	1 Participants	0 Participants	1 Participants
Age, Customized Between 18 and 65 years	22 Participants	20 Participants	42 Participants
Region of Enrollment UNITED STATES	23 Participants	20 Participants	43 Participants
Sex: Female, Male Female	4 Participants	4 Participants	8 Participants
Sex: Female, Male Male	19 Participants	16 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	12 / 23	17 / 20
serious Total, serious adverse events	0 / 23	0 / 20

Outcome results

Primary

Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184

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.