A Phase 2A Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

A Phase 2A, Open-label, Dose-ranging and Pharmacokinetic Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653379
• Other study ID #: 2MD-7H-2A
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2012
• Last updated: August 14, 2017
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2017
• Source: Deltanoid Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, dose-ranging study of the vitamin D analog DP001 in patients with end-stage renal disease (ESRD). The primary goals of this 4-week Phase 2A study are to identify an appropriate starting dose of DP001 to be used in subsequent studies in this population and for evaluation of pharmacokinetics of DP001 in ESRD patients.

Description:

Vitamin D hormone or analogs, when bound to the vitamin D receptor, suppress PTH synthesis by binding to a negative regulatory element in the promoter of the PTH gene, and have been used successfully in the clinic to reduce elevated PTH levels in dialysis patients and other CKD patients. DP001 is a highly potent vitamin D compound.

In two clinical trials testing DP001 in postmenopausal women, oral DP001 reduced PTH levels in a dose-dependent manner, with a dose of 220 ng lowering PTH by at least 30% in a majority of patients following one or six months of daily dosing.

This study is an open-label, dose-ranging study of DP001 in ESRD patients with secondary hyperparathyroidism. Cohorts of up to 6 patients will be enrolled and administered oral DP001 at 110 ng three times per week for four weeks. Laboratory data from each cohort will be assessed and used to determine a dose for the next cohort. Up to 5 dose-ranging cohorts will be studied, with the goal of identifying an appropriate dose for a randomized, placebo-controlled study of oral DP001 for 12 weeks. The data will also be used to select an appropriate dose for an additional cohort of 12 open-label patients in the current study in which the pharmacokinetics of DP001 following a single dose and after repeated doses will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months

• Plasma intact PTH value >/= 300 pg/mL

Exclusion Criteria:

• Currently taking drugs affecting vitamin D metabolism

• History of symptomatic ventricular dysrhythmias, congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, or coronary artery bypass grafting

• Active malignancy

• Clinically significant liver disease

• Active infections

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• DP001
DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deltanoid Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intact parathyroid hormone levels in blood		Baseline and 4 weeks
Secondary	Blood levels of DP001	1, 2, 4, 8, 24, and 48 hours following a single dose; 1, 2, 4, 8, 24, 48, 72, and 96 hours following multiple doses	Multiple time points following single dose and 4 weeks of dosing

External Links

•   To obtain contact information for a study center near you, click here: