Clinical trial NCT01732263: Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
timeFrame: Over 96 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of SSP-004184
timeFrame: Over 96 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax) for SSP-004184
timeFrame: Over 96 hours post-dose
measure: Plasma Half-Life (T 1/2) of SSP-004184
timeFrame: Over 96 hours post-dose
measure: Total Body Clearance (CL/F) of SSP-004184
timeFrame: Over 96 hours post-dose
measure: Volume of Distribution (Vz/F) of SSP-004184
timeFrame: Over 96 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRC)
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: