Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function

NCT01716455 | Completed Phase 1 Results

• 1 other identifier: SPD602-104
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.

Conditions

Impaired Renal Function

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

SSP-004184 (Mild Renal Impairment)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1

Drug: SSP-004184

SSP-004184 (Moderate Renal Impairment)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1

Drug: SSP-004184

SSP-004184 (Severe Renal Impairment)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1

Drug: SSP-004184

SSP-004184 (End Stage Renal Disease)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1

Drug: SSP-004184

SSP-004184 (Healthy Elderly Subjects)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1

Drug: SSP-004184

SSP-004184 (Matched Healthy Subjects)

EXPERIMENTAL

All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.)

Drug: SSP-004184

Interventions

SSP-004184 DRUG

Also known as: SPD602, FBS0701

SSP-004184 (End Stage Renal Disease); SSP-004184 (Healthy Elderly Subjects); SSP-004184 (Matched Healthy Subjects); SSP-004184 (Mild Renal Impairment); SSP-004184 (Moderate Renal Impairment); SSP-004184 (Severe Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Age 18-85 years inclusive at the time of consent. The elderly treatment group will be defined by an age over 65 years. It is required that at least 4 of the subjects in the elderly group will be over 75 years old.
• All subjects will be "healthy"
• Normal renal function (in 18-65 year-old subjects), defined as an estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study of \>90 mL/min/ 1.73 m2 at the Screening Visit.
• The stability of renal function will be confirmed by 2 determinations of serum creatinine separated by at least 7 days
• Subjects with renal impairment
• Age 18-85 years inclusive at the time of consent.
• Estimated glomerular filtration rate from the MDRD Study is to be estimated at the Screening Visit and should be as described in FDA guidance.
• Subjects must have no clinically significant abnormalities (except for abnormalities explained by the renal impairment disorder).
• All subjects
• 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.
• An understanding, ability, and willingness to fully comply with study procedures and restrictions.

You may not qualify if:

• Healthy subjects
• Subject has a clinically significant history or a disorder detected during the medical interview/physical examination
• Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
• History of diabetes mellitus, nephrotic syndrome (defined as plasma albumin \<30 g/dL and/or proteinuria \>3 g/day), or other metabolic endocrine disease known to be associated with alterations in plasma lipid levels. Uncontrolled hypothyroidism is defined as thyroid stimulating hormone (TSH) 1.5 times greater than the upper limit of normal (ULN).
• Subjects with renal impairment
• Current or recurrent disease, other than impaired renal function that could affect, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
• Concurrent chronic or acute illness or unstable medical condition (other than those associated with their renal disease) that may deteriorate and thus confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
• A potassium concentration \>6.2 mmol/L at the Screening Visit.
• Subjects with a renal transplant.
• History of nephrotic syndrome (defined as plasma albumin \<30 g/dL and/or proteinuria \>3 g/day), or other metabolic endocrine disease known to be associated with alterations in plasma lipid levels (uncontrolled hypothyroidism defined as TSH 1.5 times greater than the upper reference range value).
• Subjects on peritoneal dialysis.
• Uncontrolled systolic or diastolic blood pressure as defined by the investigator.
• Liver enzymes (ALT, AST, GGT) more than 2 fold above ULN at the Screening Visit or on Day -2.
• Uncontrolled diabetes mellitus as determined by the investigator.
• Congestive Heart Failure classified New York Heart Association (NYHA) Class III or IV.

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

Conditions

Renal Insufficiency

Interventions

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

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 29, 2012
• Primary Completion: March 10, 2013
• Study Completion: March 10, 2013
• Last Updated: June 10, 2021
• Results First Posted: February 19, 2014

Record last verified: 2021-05

Locations

US (2)