Clinical trial NCT01217736 (phase 1, status: completed)
Conditions: renal function
ICD codes: N25.89, N25.9
Drugs: aliskiren, placebo, vtp-27999
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@](CN=C(O)N1CCC[C@]([H])(C1)[C@@]([H])(OCCN=C(O)OC)C1=CC(Cl)=CC=C1)(C[C@@]1([H])CCCOC1)NC
Eligibility criteria:

        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