Direct Renin Inhibition and the Kidney

Vitae Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Renal Function

Treatments

Drug: VTP-27999

Drug: placebo

Drug: aliskiren

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01217736

2010P001281 (Other Identifier)

VTP-27999-005

Details and patient eligibility

About

The objective of the study is to determine the magnitude of the effect of direct renin inhibition by VTP-27999 on renal plasma flow and kidney function.

Enrollment

22 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult male or female, 18-75 years of age
Female subjects must be postmenopausal or surgically sterilized. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by plasma serum FSH level at screening between 23.0-116.3 mIU/ml. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing.
Male subjects, able to father a child, must be willing to use approved birth control methods for 2 weeks following completion of study.

Exclusion criteria

Subjects under 18 and subjects over 75 years
Diabetes Mellitus and/or kidney disease
Myocardial infarction, stroke, or cardiovascular revascularization/angioplasty within the last 6 months
Unstable angina pectoris or CAD requiring treatment with an excluded concomitant medication
History of/or symptoms consistent with congestive heart failure
Hypertension
History of left ventricular ejection fraction < 45%
Current smokers or nicotine patch
Pregnant or lactating females
Cancer or any life threatening illness with expected death within 2 years or by completion of the study
Serum creatinine >1.4 mg/dl
Serum potassium <3.5 or >5.2 mmol/L without medication
Serum albumin < 2.0 g/dL
Hemoglobin < 11.5 g/dL or Hematocrit < 34%
Any serum AST >/= 60 or ALT >/= 75 IU/L
Use of any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics are not allowed within 10 days prior to dosing or during the study
Use of CYP3A4 inhibitors (e.g. Diltiazem, Ketoconazole, Nifedipine, or Verapamil)
Use of any prescription medication is prohibited within 14 days (or, if known, for at least 5 half-lives, if longer) prior to dosing, unless approved by both the Investigator and the Sponsor
Use of any over-the-counter (OTC) medication, including herbal products, is prohibited within the 14 days prior to dosing, unless approved by both the Investigator and the Sponsor
Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
A known hypersensitivity or contraindication to the study drugs (Aliskiren) or drugs similar to the study drugs or PAH, and inulin
Any surgical or medical condition which alters absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient subject during this study, including gastric bypass
History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by past medical history
Acute infections and/or significant illness within 3 weeks of planned enrollment into this study
Any medical condition in the investigator's opinion, which renders the subject unable to complete the study or which would produce significant risk to the subject
Administration of any other investigational drug within 30 days of planned dosing in the study
Poor intravenous (IV) access as determined by the study staff