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

OPKO Health

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease; Chronic Renal Failure; Chronic Renal Insufficiency; Secondary Hyperparathyroidism

Treatments: Drug: CTAP101 Capsules; Drug: CTAP101 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888069

CTAP101-CL-2004

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Low Dose CTAP101 Capsules

Experimental group

Description:

CTAP101 Capsules, 450 mcg dose

Treatment:

Drug: CTAP101 Capsules

High Dose CTAP101 Capsules

Experimental group

Description:

CTAP101 Capsules, 900 mcg dose

Treatment:

Drug: CTAP101 Capsules

CTAP101 Injection

Experimental group

Description:

IV injection, 448 mcg dose

Treatment:

Drug: CTAP101 Injection