Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Opko Health, Inc. ( OPKO IP Holdings II, Inc. )
ClinicalTrials.gov Identifier:
NCT00888069
First received: April 23, 2009
Last updated: September 29, 2014
Last verified: February 2010

April 23, 2009
September 29, 2014
May 2009
November 2009   (final data collection date for primary outcome measure)
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT [ Time Frame: from 3 to 0 hours prior to dosing until 42 days post dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00888069 on ClinicalTrials.gov Archive Site
  • To assess the safety and tolerability of CTAP101 capsules and injection [ Time Frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing) ] [ Designated as safety issue: Yes ]
  • To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT. [ Time Frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Secondary Hyperparathyroidism
  • Chronic Renal Insufficiency
  • Chronic Renal Failure
  • Drug: CTAP101 Capsules
    Single dose oral administration
  • Drug: CTAP101 Injection
    single IV injection
  • Experimental: Low Dose CTAP101 Capsules
    CTAP101 Capsules, 450 mcg dose
    Intervention: Drug: CTAP101 Capsules
  • Experimental: High Dose CTAP101 Capsules
    CTAP101 Capsules, 900 mcg dose
    Intervention: Drug: CTAP101 Capsules
  • Experimental: CTAP101 Injection
    IV injection, 448 mcg dose
    Intervention: Drug: CTAP101 Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
  • Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
  • Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
  • Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
  • Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
  • Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
  • Hemoglobin level greater than or equal to 10 g/dL

Exclusion Criteria:

  • Has nephrotic range proteinuria
  • Has liver disease or significant hepatic dysfunction
  • Is taking Cytochrome P450 3A4 inhibitors or inducers
  • Has adult history of kidney stones and dysphagia
  • Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
  • Currently on dialysis
  • Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00888069
CTAP101-CL-2004
No
Opko Health, Inc. ( OPKO IP Holdings II, Inc. )
OPKO IP Holdings II, Inc.
Not Provided
Study Director: Joel Melnick, MD OPKO Renal
Opko Health, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP