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

A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HQK-1001; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98403
      • Charles River Clinical Services Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: placebo; Matching placebo capsules administered once a day, orally, for 14 days.
EXPERIMENTAL: 1; HQK-1001	Drug: HQK-1001; HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam	41 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics assessed by plasma drug concentration levels	15 days
Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin	41 days
Comparison of safety, PK and PD under fed versus fasting conditions	41 days
Comparison of safety and PK when oral iron is administered with HQK-1001.	41 days

Collaborators and Investigators

• Sponsor: HemaQuest Pharmaceuticals Inc.
• Investigators: Principal Investigator: Robin Downey, MD, Charles River Clinical Services Northwest

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (ESTIMATE): July 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2009
• Last Update Submitted That Met QC Criteria: January 15, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: HQP 2008-002