HealthyPhase 1NCT00717262
Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects
A Phase 1 study testing HQK-1001 in people with Healthy, run by HemaQuest Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HQK-1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Services Northwest
Tacoma, Washington, 98403
About this study
Official title: A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers
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
- Being tested
- HQK-1001, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQK-1001Drug
HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days.
placeboDrug
Matching placebo capsules administered once a day, orally, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HQK-1001 Receives: Drug: HQK-1001 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Measured: 41 days
Secondary outcomes (4)
Pharmacokinetics assessed by plasma drug concentration levels
Measured: 15 days
Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin
Measured: 41 days
Comparison of safety, PK and PD under fed versus fasting conditions
Measured: 41 days
Comparison of safety and PK when oral iron is administered with HQK-1001.
Measured: 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HemaQuest Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robin Downey, MD, Principal investigator, Charles River Clinical Services Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717262
- Sponsor's protocol ID
- HQP 2008-002
- Status last verified
- Jan 2009
- First submitted
- 15 Jul 2008
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo Controlled, Repeat-Dose Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00717262
- Acronym / sponsor ID
- HQP 2008-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- HemaQuest Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HQK-1001HQK-1001 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HQK-1001HQK-1001 (5, 10 or 15 mg/kg) capsules administered once a day, orally, for 14 days. | Drug | 1 |
| placeboMatching placebo capsules administered once a day, orally, for 14 days. | Drug | 2 |
Primary outcome
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Time frame: 41 days
4 secondary outcomes
Pharmacokinetics assessed by plasma drug concentration levels
Time frame: 15 days
Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin
Time frame: 41 days
Comparison of safety, PK and PD under fed versus fasting conditions
Time frame: 41 days
Comparison of safety and PK when oral iron is administered with HQK-1001.
Time frame: 41 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Downey, MD principal investigator
Charles River Clinical Services Northwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HQK-1001 in people with Healthy, run by HemaQuest Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam (time frame: 41 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009.