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

Inclusion Criteria

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.
• Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study related procedures. The date of signing informed consent is defined as the beginning of the Screening Period
• Body mass index between 18.5-40.0 kg/m² inclusive. This inclusion criterion will only be assessed at the Screening Visit.
• Hemoglobin of 9.0 g/dL or greater at the Screening Visit and Day -2.
• No clinically significant deviations from the reference ranges for clinical laboratory tests as evaluated by the investigator. Low-density lipoprotein cholesterol value must be 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 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.
• Any major illness that would in the opinion of the investigator put study subject at risk or interfere with study conduct.

All subjects

• Acute illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
• Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
• Subject has a history of thyroid disorde