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

NCT01453634 | Withdrawn Phase 2

• 1 other identifier: CTA018-2007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.

Conditions

Stage 5 Chronic Kidney Disease (CKD); Secondary Hyperparathyroidism (SHPT); Hemodialysis (HD)

Keywords

chronic kidney disease (CKD); secondary hyperparathyroidism (SHPT); hemodialysis (HD)

Outcome Measures

Primary Outcomes (1)

• Measure the intact parathyroid hormone (iPTH) levels following Lunacalcipol Injection

  3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.

Secondary Outcomes (1)

• Assess the safety of Lunacalcipol Injection

  3 screening visits will occur within up to 42 days, Subjects will receive a total of 11 doses of study drug given 3 times weekly over 24 days. Following 24 days of treatment, subjects will undergo 2 days of follow-up and an end of study (EOS) assessment.

Study Arms (2)

Lunacalcipol 180

EXPERIMENTAL

180 µg (n=4)Lunacalcipol Injection

Drug: Lunacalcipol 180

Lunacalcipol 270

EXPERIMENTAL

270 µg (n=8)Lunacalcipol Injection

Drug: Lunicalcipol 270

Interventions

Lunacalcipol 180 DRUG

4 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.

Lunacalcipol 180

Lunicalcipol 270 DRUG

8 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.

Lunacalcipol 270

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OPKO Health, Inc.: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 22, 2014

Record last verified: 2014-09