Overview

Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)

Status:
Withdrawn
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
Summary
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OPKO Health, Inc.
Criteria
Inclusion Criteria:

- Subject must have a body mass index (BMI) between 18 and 35 kg/m2, inclusive.

- Prior to study entry, subjects must be undergoing maintenance HD tiw, be in stable
condition (ie, on maintenance HD for at least 8 weeks) and be expected to remain on HD
for the duration of the study.

- Subject must be willing and able to discontinue vitamin D and/or bone metabolism
therapy for a minimum 2 week wash-out prior to administration of study drug and
through the EOS visit. This includes vitamin D supplements daily dose containing more
than 1000 IU of ergocalciferol or cholecalciferol) and analogs (calcitriol,
paricalcitol, doxercalciferol), cinacalcet, teriparatide, calcitonin, maintenance
glucocorticoids (greater than a prednisone equivalent of 5 mg/day), selective estrogen
receptor modulators (SERMs; raloxifene or tamoxifen) or other drugs that may affect Ca
metabolism.

- Subjects must not have taken bisphosphonates for at least 3 months (90 days) prior to
the first dose of study drug.

- Subject laboratory values must be within the following ranges:

- Plasma iPTH ≥350 pg/mL (35 pmol/L) and <1000 pg/mL (100 pmol/L)

- Total serum Ca ≥8.4 mg/dL (2.1 mmol/L) and <10.0 mg/dL (2.5 mmol/L)

- Serum P ≥2.5 mg/dL (0.8 mmol/L) and <6.2 mg/dL (2.0 mmol/L)

- Total serum 25-hydroxyvitamin D level at screening must be ≥15 ng/mL (37 nmol/L).

- Subject must be willing and able to comply with study instructions and commit to all
clinic visits for the duration of the study.

- Female subjects of childbearing potential must be neither pregnant nor lactating and
must have a negative serum pregnancy test at screening and agree to use effective
contraception (implants, injectables, combined oral contraceptives, intrauterine
device (IUD), sexual abstinence, or vasectomized partner) for the duration of the
study.

Exclusion Criteria:

- Subject cannot have clinically significant liver disease (alanine aminotransferase
[ALT], aspartate amino transferase [AST] or bilirubin > 2x ULN), or any clinical
evidence of significant hepatic dysfunction during the screening period deemed
clinically significant by the investigator.

- Subject cannot be currently taking cytochrome P450 3A inhibitors (eg, ketoconazole or
erythromycin) or P450 3A inducers.

- Subject cannot have a known history of kidney stones within the previous 2 years.

- Subject cannot have a known previous or concomitant serious illness or medical
condition, such as malignancy, human immunodeficiency virus (HIV) or hepatitis that in
the opinion of the investigator may worsen and/or interfere with participation in the
study.

- Subject cannot have a history of neurological/psychiatric disorders, including
psychotic disorders or dementia, or any other reason, which in the opinion of the
investigator makes adherence to a regular treatment or follow-up schedule unlikely.

- Subject cannot have any clinically significant abnormalities, as determined by the
investigator, based on a 12-lead ECG, PE and laboratory assessments conducted during
screening.

- Subject cannot have a known or suspected hypersensitivity to any of the constituents
of the investigational product.

- Subject cannot be currently participating in or have participated in an
interventional/investigational study within 30 days prior to the study.