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

NCT01453634 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-09-22

No results posted yet for this study

Summary

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

Conditions

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

Interventions

DRUG

Lunacalcipol 180

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.

DRUG

Lunicalcipol 270

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.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-07-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453634 on ClinicalTrials.gov