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

Sponsor
HemaQuest Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00717262
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
4
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam [41 days]

Secondary Outcome Measures

  1. Pharmacokinetics assessed by plasma drug concentration levels [15 days]

  2. Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin [41 days]

  3. Comparison of safety, PK and PD under fed versus fasting conditions [41 days]

  4. Comparison of safety and PK when oral iron is administered with HQK-1001. [41 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00717262
Other Study ID Numbers:
  • HQP 2008-002
First Posted:
Jul 17, 2008
Last Update Posted:
Jan 16, 2009
Last Verified:
Jan 1, 2009

Study Results

No Results Posted as of Jan 16, 2009