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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure

Intervention / Treatment
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* Drug: CTAP101 Capsules
* Drug: CTAP101 Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose CTAP101 Capsules<br>CTAP101 Capsules, 450 mcg dose | Drug: CTAP101 Capsules<br>* Single dose oral administration<br>|
| Experimental: High Dose CTAP101 Capsules<br>CTAP101 Capsules, 900 mcg dose | Drug: CTAP101 Capsules<br>* Single dose oral administration<br>|
| Experimental: CTAP101 Injection<br>IV injection, 448 mcg dose | Drug: CTAP101 Injection<br>* single IV injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT |  | from 3 to 0 hours prior to dosing until 42 days post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of CTAP101 capsules and injection |  | From signing of ICF (Day -35) through study completion (Day 42 post dosing) | 
| To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT. |  | From signing of ICF (Day -35) through study completion (Day 42 post dosing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure