HealthyPhase 1NCT00619931
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
A Phase 1 study testing APD791 in people with Healthy, run by Arena Pharmaceuticals at 1 site in United States.
Trial summary
The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- APD791
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women, ages 19-45
- Non smokers
Who cannot join
- History of a bleeding disorder
- Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
- Recently donated blood or had significant blood loss
- Current use of a prescription medication
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.
- Conditions
- Healthy
- Being tested
- APD791
- Keywords
- Healthy adult volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD791Drug
APD791 or matching placebo in escalating doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | APD791 or placebo Receives: Drug: APD791 |
| 2 | Experimental | APD791 or placebo Receives: Drug: APD791 |
| 3 | Experimental | APD791 or placebo Receives: Drug: APD791 |
| 4 | Experimental | APD791 or placebo Receives: Drug: APD791 |
| 5 | Experimental | APD791 or placebo Receives: Drug: APD791 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
Measured: Throughout study duration
Secondary outcomes (2)
Pharmacokinetic assessments
Measured: Throughout study duration
Pharmacodynamic assessments (e.g., platelet function)
Measured: Throughout study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Kisicki, MD, Principal investigator, MDS Pharma ServicesChristen M Anderson, MD, PhD, Study director, Arena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619931
- Sponsor's protocol ID
- APD791-002
- Status last verified
- Jun 2022
- First submitted
- 11 Feb 2008
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00619931
- Acronym / sponsor ID
- APD791-002
- Conditions
- Healthy
- Keywords
- Healthy adult volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Feb 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 APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: APD791APD791 or placebo |
| 2 | Experimental | Drug: APD791APD791 or placebo |
| 3 | Experimental | Drug: APD791APD791 or placebo |
| 4 | Experimental | Drug: APD791APD791 or placebo |
| 5 | Experimental | Drug: APD791APD791 or placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult men and women, ages 19-45
- Non smokers
Key exclusion criteria (5 listed)
- History of a bleeding disorder
- Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
- Recently donated blood or had significant blood loss
- Current use of a prescription medication
- Pregnant females
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 |
|---|---|---|
| APD791APD791 or matching placebo in escalating doses | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
Time frame: Throughout study duration
2 secondary outcomes
Pharmacokinetic assessments
Time frame: Throughout study duration
Pharmacodynamic assessments (e.g., platelet function)
Time frame: Throughout study duration
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 5 Jul 2022.
- Arena Home PageLink provided by the sponsor.
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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.
James Kisicki, MD principal investigator
MDS Pharma Services
Christen M Anderson, MD, PhD study director
Arena Pharmaceuticals
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 APD791 in people with Healthy, run by Arena Pharmaceuticals 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 2 inclusion and 5 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 5 Jul 2022. 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. 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 measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters (time frame: Throughout study duration). 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 5 Jul 2022.