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

HemaQuest Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: HQK-1001

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00717262

HQP 2008-002

Details and patient eligibility

About

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.

Enrollment

41 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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