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

This study has been completed.
Sponsor:
Information provided by:
HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00717262
First received: July 15, 2008
Last updated: January 15, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: HQK-1001
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers

Further study details as provided by HemaQuest Pharmaceuticals Inc.:

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: 41
Study Start Date: May 2008
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HQK-1001
Drug: HQK-1001
HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.
Placebo Comparator: 2 Drug: placebo
Matching placebo capsules administered once a day, orally, for 14 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717262

Locations
United States, Washington
Charles River Clinical Services Northwest
Tacoma, Washington, United States, 98403
Sponsors and Collaborators
HemaQuest Pharmaceuticals Inc.
Investigators
Principal Investigator: Robin Downey, MD Charles River Clinical Services Northwest
  More Information

No publications provided

Responsible Party: Susan Perrine, MD/ Chief Scientific Officer, HemaQuest Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00717262     History of Changes
Other Study ID Numbers: HQP 2008-002
Study First Received: July 15, 2008
Last Updated: January 15, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014