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

HemaQuest Pharmaceuticals Inc.1 site in 1 country41 target enrollmentMay 2008

ConditionsHealthy

InterventionsHQK-1001 placebo

DrugsHQK-1001 placebo

Overview

Phase: Phase 1
Intervention: HQK-1001
Conditions: Healthy
Sponsor: HemaQuest Pharmaceuticals Inc.
Enrollment: 41
Locations: 1
Primary Endpoint: Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

September 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HemaQuest Pharmaceuticals Inc.

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

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

Arms & Interventions

1

HQK-1001

Intervention: HQK-1001

2

Intervention: placebo

Outcomes

Primary Outcomes

Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam

Time Frame: 41 days

Secondary Outcomes

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)