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

NCT01732263 | Completed Phase 1 Results

• 1 other identifier: SPD602-105
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment; Healthy

Outcome Measures

Primary Outcomes (6)

• 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.

  Over 96 hours post-dose

• Maximum Plasma Concentration (Cmax) of SSP-004184

  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.

  Over 96 hours post-dose

• Time of Maximum Plasma Concentration (Tmax) for SSP-004184

  Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

  Over 96 hours post-dose

• Plasma Half-Life (T 1/2) of SSP-004184

  The time it takes for the blood plasma concentration of a substance to halve.

  Over 96 hours post-dose

• Total Body Clearance (CL/F) of SSP-004184

  The rate at which a drug is removed from the body.

  Over 96 hours post-dose

• Volume of Distribution (Vz/F) of SSP-004184

  The distribution of a medication between plasma and the rest of the body.

  Over 96 hours post-dose

Study Arms (4)

SSP-004184 (Child-Pugh A Liver Impaired)

EXPERIMENTAL

The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.

Drug: SSP-004184

SSP-004184 (Child-Pugh B Liver Impaired)

EXPERIMENTAL

Drug: SSP-004184

SSP-004184 (Child-Pugh C Liver Impaired)

EXPERIMENTAL

Drug: SSP-004184

SSP-004184 (Matched Healthy Subjects)

EXPERIMENTAL

Drug: SSP-004184

Interventions

SSP-004184 DRUG

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

Also known as: SPD602, FBS0701

SSP-004184 (Child-Pugh A Liver Impaired); SSP-004184 (Child-Pugh B Liver Impaired); SSP-004184 (Child-Pugh C Liver Impaired); SSP-004184 (Matched Healthy Subjects)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (2)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

4,5-dihydro-2-(2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl)-4-methyl-4-thiazolecarboxylic acid

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: November 9, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 19, 2021
• Results First Posted: May 15, 2014

Record last verified: 2021-06

Locations

US (2)