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NCT Number: NCT00888069

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

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).

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Renal Failure Chronic Renal Insufficiency Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Secondary Hyperparathyroidism Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pivotal Research Centers, Peoria, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTAP101 Capsules

Drug

Single dose oral administration

CTAP101 Injection

Drug

single IV injection

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

OPKO IP Holdings II, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 24, 2009
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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