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

NCT00717262 | Completed Phase 1

• 1 other identifier: HQP 2008-002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  41 days

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

HQK-1001

Drug: HQK-1001

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

HQK-1001 DRUG

HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.

1

placebo DRUG

Matching placebo capsules administered once a day, orally, for 14 days.

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HemaQuest Pharmaceuticals Inc.: lead

Study Sites (1)

Charles River Clinical Services Northwest

Tacoma, Washington, 98403, United States

Location

MeSH Terms

Interventions

2,2-dimethylbutyric acid

Study Officials

• Robin Downey, MD

  Charles River Clinical Services Northwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 16, 2009

Record last verified: 2009-01

Locations

US (1)