Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects

NCT01757860 | Completed Phase 1 DMC

• 1 other identifier: CARD-024-C001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Study Phase: Phase 1 Primary Objective:

• To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in healthy subjects Secondary Objectives:
• To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral doses of CARD-024
• To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin activity (PRA) and blood pressure (BP), biological markers of activity, following ascending single oral doses of CARD-024

Conditions

Drug Safety; Heart; Disease, Activity

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.

  5 days

Secondary Outcomes (2)

• Drug Pharmacokinetics

  5 days

• Drug Pharmacodynamics

  5 days

Other Outcomes (1)

• Induction of Hypercalcemia

  5 days

Study Arms (2)

CARD-024

EXPERIMENTAL

CARD-024 oral administered: 3, 9, 27 or 81 mcg.

Drug: CARD-024

Drug Carrier

PLACEBO COMPARATOR

Placebo: 20% ethanol:80% propylene glycol solution oral administered.

Other: Drug Carrier

Interventions

CARD-024 DRUG

Comparison of different dosages of drug

Also known as: 1α-Hydroxy-Vitamin-D5; 1αVitD5

CARD-024

Drug Carrier OTHER

Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.

Also known as: Placebo, Drug Carrier

Drug Carrier

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females between the ages of 18 and 55, inclusive, with body mass index (BMI) between 18-32 kg/m2.
• Females must be surgically sterile or at least 2 years post-menopausal. Menopausal status will be verified by a follicular stimulating hormone (FSH) test. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screening.
• No clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. No clinically significant medical history.
• No clinically significant safety laboratory results at Screening. Cardiavent, Inc. - CONFIDENTIAL
• Nonsmoker or light smoker (≤5 cigarettes per day or similar use of other tobacco products) and are willing to refrain from smoking while in the clinic.
• Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
• Willing and able to stay in the clinic for the inpatient activities required by the protocol for all visits.

You may not qualify if:

• Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
• Current or recurrent disease that may affect the action, absorption, or disposition of the study treatment, or clinical or laboratory assessments.
• Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
• History of febrile illness within the 5 days prior to the first dose.
• Positive Hepatitis B surface antigen (HbsAg), Hepatitis C antibody or Human Immunodeficiency Virus (HIV) test result at Screening visit.
• Use of any prescription medication or over-the-counter (OTC) medication within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication or during the study. As an exception, acetaminophen may be used at doses up to 1 g/day.
• Use of any herbal supplements (including herbal weight-loss or "metabolism booster" therapies) within 30 days prior to the first dose of trial medication.
• Known or suspected intolerance or hypersensitivity to similar study drugs or excipients, closely related compounds or any of their stated ingredients.
• Positive screen for alcohol or drugs of abuse during Screening visit or at study check-in for Day 1 dosing.
• Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
• Blood donation of 1 pint or more within 56 days of the start of the study.
• Plasmapheresis or plasma donation within 30 days of the start of the study.
• Single 12-lead ECG demonstrating QTc \>450 msec at Screening, and or history or evidence of long QT syndrome. A single repeat ECG may be done at the Principal Investigator's discretion.
• Any condition that in the opinion of the Principal Investigator would complicate or compromise the study or the well-being of the subject.
• Unwilling or unable to comply with the clinic house rules.

Sponsors & Collaborators

• Cardiavent Inc.: lead

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Disease; Motor Activity

Interventions

Drug Carriers

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Drug Delivery Systems; Drug Therapy; Therapeutics

Study Officials

• James Vanderlugt, MD

  Jasper Clinic, Michigan

  PRINCIPAL INVESTIGATOR

• Robert U Simpson, PhD

  Cardiavent Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 31, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 31, 2012

Record last verified: 2012-12

Locations

US (1)