Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects
This study has been completed.
Information provided by:
HemaQuest Pharmaceuticals Inc.
First received: July 15, 2008
Last updated: January 15, 2009
Last verified: January 2009
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.
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers
Primary Outcome Measures:
- Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam [ Time Frame: 41 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics assessed by plasma drug concentration levels [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin [ Time Frame: 41 days ] [ Designated as safety issue: No ]
- Comparison of safety, PK and PD under fed versus fasting conditions [ Time Frame: 41 days ] [ Designated as safety issue: Yes ]
- Comparison of safety and PK when oral iron is administered with HQK-1001. [ Time Frame: 41 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2008 (Final data collection date for primary outcome measure)
HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.
Placebo Comparator: 2
Matching placebo capsules administered once a day, orally, for 14 days.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717262
|Charles River Clinical Services Northwest
|Tacoma, Washington, United States, 98403 |
HemaQuest Pharmaceuticals Inc.
||Robin Downey, MD
||Charles River Clinical Services Northwest
No publications provided
ClinicalTrials.gov processed this record on August 19, 2014
||Susan Perrine, MD/ Chief Scientific Officer, HemaQuest Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 15, 2008
||January 15, 2009
||United States: Food and Drug Administration