Hepatic ImpairmentPhase 1NCT01732263

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

A Phase 1 study testing SSP-004184 in people with Hepatic Impairment and Healthy, run by Shire at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy
What is being tested?: SSP-004184
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 2 sitesUnited States
Study dates: 9 Nov 2012to 1 Apr 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809

Other trials in United States

About this study

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

Conditions: Hepatic Impairment, Healthy
Being tested: SSP-004184

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SSP-004184Drug
Also called SPD602, FBS0701
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Study groups in NCT01732263
Study group	Role	What they receive
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. Receives: Drug: SSP-004184
SSP-004184 (Child-Pugh B Liver Impaired)	Experimental	Not described Receives: Drug: SSP-004184
SSP-004184 (Child-Pugh C Liver Impaired)	Experimental	Not described Receives: Drug: SSP-004184
SSP-004184 (Matched Healthy Subjects)	Experimental	Not described Receives: Drug: SSP-004184

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 96 hours post-dose
Total Body Clearance (CL/F) of SSP-004184
The rate at which a drug is removed from the body.
Measured: 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.
Measured: Over 96 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 20121 Apr 2013

First posted22 Nov 2012 (estimated)
Study start9 Nov 2012
Primary completion1 Apr 2013
Study completion1 Apr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732263
Sponsor's protocol ID: SPD602-105
Status last verified: Jun 2021
First submitted: 19 Nov 2012
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01732263
Acronym / sponsor ID: SPD602-105
Conditions: Hepatic Impairment, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 9 Nov 2012 (actual)
Primary completion: 1 Apr 2013 (actual)
Study completion: 1 Apr 2013 (actual)
First posted: 22 Nov 2012 (estimated)
Results: Posted 15 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
SSP-004184 (Child-Pugh A Liver Impaired)	Experimental	Drug: SSP-004184The 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.
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SSP-004184Also: SPD602, FBS0701All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1	Drug	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)

Primary outcome

Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Over 96 hours post-dose
The rate at which a drug is removed from the body.
Volume of Distribution (Vz/F) of SSP-004184
Time frame: Over 96 hours post-dose
The distribution of a medication between plasma and the rest of the body.

Results and safety

Results posted to the registry on 15 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hepatic Impairment	23	23
Matched Healthy Subjects	20	20

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

Time frame: Over 96 hours post-dose. Mean (Standard Deviation). Unit: ng*h/ml

Measure	SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg n = 8	SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg n = 5	SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg n = 3	SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg n = 7	SSP-004184 (Matched Healthy Subjects) 45 mg/kg n = 10	SSP-004184 (Matched Healthy Subjects) 50 mg/kg n = 10
Value	254327.7 (57645.3)	443053.5 (157352.1)	288579.6 (149123.5)	410414.3 (111201.8)	209989.8 (83155.2)	310281.3 (112004.9)

Population analysed: Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Primary outcome: Maximum Plasma Concentration (Cmax) of SSP-004184

Time frame: Over 96 hours post-dose. Mean (Standard Deviation). Unit: ng/ml

Measure	SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg n = 8	SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg n = 5	SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg n = 3	SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg n = 7	SSP-004184 (Matched Healthy Subjects) 45 mg/kg n = 10	SSP-004184 (Matched Healthy Subjects) 50 mg/kg n = 10
Value	98887.5 (29689.1)	121460.0 (28777.7)	109166.7 (52920.5)	123985.0 (34807.1)	83350.0 (28538.1)	108890.0 (41016.6)

Primary outcome: Time of Maximum Plasma Concentration (Tmax) for SSP-004184

Time frame: Over 96 hours post-dose. Median (Full Range). Unit: hours

Measure	SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg n = 8	SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg n = 5	SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg n = 3	SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg n = 7	SSP-004184 (Matched Healthy Subjects) 45 mg/kg n = 10	SSP-004184 (Matched Healthy Subjects) 50 mg/kg n = 10
Value	1.3 (1.0 to 1.5)	1.5 (1.0 to 2.5)	1.5 (1.0 to 1.5)	1.5 (1.0 to 2.5)	1.0 (1.0 to 1.5)	1.0 (1.0 to 2.0)

Primary outcome: Plasma Half-Life (T 1/2) of SSP-004184

Time frame: Over 96 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg n = 8	SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg n = 5	SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg n = 3	SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg n = 7	SSP-004184 (Matched Healthy Subjects) 45 mg/kg n = 10	SSP-004184 (Matched Healthy Subjects) 50 mg/kg n = 10
Value	21.91 (17.54)	11.37 (6.47)	6.93 (0.94)	6.79 (3.97)	12.51 (4.51)	16.19 (8.62)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hepatic Impairment	0 of 23 (0%)	12 of 23 (52.2%)	Not reported
Matched Healthy Subjects	0 of 20 (0%)	17 of 20 (85%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatic Impairment

Not yet recruitingPhase 1
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RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SSP-004184 in people with Hepatic Impairment and Healthy, run by Shire at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184 (time frame: Over 96 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.