Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects

NCT ID: NCT00717262

Last Updated: 2009-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

HQK-1001

Group Type: EXPERIMENTAL

HQK-1001

Intervention Type: DRUG

HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Matching placebo capsules administered once a day, orally, for 14 days.

Interventions

HQK-1001

HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.

Intervention Type: DRUG

placebo

Matching placebo capsules administered once a day, orally, for 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male or female
• Between the ages of 18 and 45 years old
• Able and willing to give informed consent
• Able to comply with all study procedures
• If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (6 months minimum); or abstinence
• Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate, throughout the course of the study
• Not receiving medications within the 2 weeks before the first dose of study medication, except for multivitamins and contraception
• Complete blood count (CBC) with white blood cell (WBC) count hemoglobin, hematocrit, reticulocyte count and platelet count within normal range for the testing facility or not clinically significant
• Serum ferritin level > 50 ng/ml in Cohort 1
• Serum ferritin level > 30 mg/ml in Cohorts 2, 3, 4 and 5
• Serum chemistry values, coagulation tests and urinalysis values within the normal range for the testing facility or not clinically significant
• Negative urine test for substances of abuse including marijuana, cocaine, opiates, and methadone

Exclusion Criteria

• Prior participation in HQP 2007-001
• Clinically significant abnormal vital signs
• Blood donation within 2 months of study medication administration
• Blood transfusion within 3 months of study medication administration
• An acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication
• Received another investigational agent within 4 weeks before administration of study medication
• Receiving any other investigational agent during this study
• Any acute or chronic disease (e.g., history of hepatitis B or C or HIV-1)
• Heart disease including an abnormal electrocardiogram, clinical significant, (ECG) or cardiac arrhythmia
• History of neurological disease, such as a seizure disorder
• Currently pregnant or breast feeding a child
• A smoker in the past 12 months
• Body Mass Index (BMI) >33 kg/m2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HemaQuest Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

HemaQuest Pharmaceuticals, Inc.

Principal Investigators

Robin Downey, MD

Role: PRINCIPAL_INVESTIGATOR

Charles River Clinical Services Northwest

Locations

Charles River Clinical Services Northwest

Tacoma, Washington, United States

Countries

United States

Other Identifiers

HQP 2008-002

Identifier Type: -

Identifier Source: org_study_id