Alzheimer's DiseasePhase 1CT02NCT01203384
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
A Phase 1 study testing CHF5074 1x, CHF5074 2x and CHF5074 3x in people with Alzheimer's Disease, run by CERESPIR at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CHF5074 1x, CHF5074 2x and CHF5074 3x
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
Who cannot join
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
- Significant allergic conditions that require medical treatment
- Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Iberica Clinical Research Center
Eatontown, New Jersey, 07724
About this study
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.
- Conditions
- Alzheimer's Disease
- Being tested
- CHF5074 1x, CHF5074 2x, CHF5074 3x, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF5074 1xDrug
oral tablet, 1x, once a day in the morning for 14 days
CHF5074 2xDrug
oral tablet, 2x, once a day in the morning for 14 days
CHF5074 3xDrug
oral tablet, 3x, once a day in the morning for 14 days
PlaceboDrug
oral tablet, placebo, once a day in the morning for 14 days
| Study group | Role | What they receive |
|---|---|---|
| CHF5074 1x | Experimental | oral tablet, multidose Receives: Drug: CHF5074 1x |
| CHF5074 2x | Experimental | oral tablet, multidose Receives: Drug: CHF5074 2x |
| CHF5074 3x | Experimental | oral tablet, multidose Receives: Drug: CHF5074 3x |
| Placebo | Placebo comparator | placebo, oral tablet, multidose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: from Screening through Day 18
Secondary outcomes (2)
Dose linearity of CHF5074 plasma levels (Cmax)
Measured: Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Measured: Day -1 through Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CERESPIR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magdy L Shenouda, MD, Principal investigator, Iberica Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203384
- Sponsor's protocol ID
- CCD-0913-PR-0038
- Acronym
- CT02
- Status last verified
- Feb 2015
- First submitted
- 15 Sep 2010
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
- ClinicalTrials.gov ID
- NCT01203384
- Acronym / sponsor ID
- CT02 / CCD-0913-PR-0038
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CERESPIRIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Sep 2010 (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, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHF5074 1x | Experimental | Drug: CHF5074 1xoral tablet, multidose |
| CHF5074 2x | Experimental | Drug: CHF5074 2xoral tablet, multidose |
| CHF5074 3x | Experimental | Drug: CHF5074 3xoral tablet, multidose |
| Placebo | Placebo comparator | Drug: Placeboplacebo, oral tablet, multidose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
Key exclusion criteria (5 listed)
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
- Significant allergic conditions that require medical treatment
- Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
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 |
|---|---|---|
| CHF5074 1xoral tablet, 1x, once a day in the morning for 14 days | Drug | CHF5074 1x |
| CHF5074 2xoral tablet, 2x, once a day in the morning for 14 days | Drug | CHF5074 2x |
| CHF5074 3xoral tablet, 3x, once a day in the morning for 14 days | Drug | CHF5074 3x |
| Placebooral tablet, placebo, once a day in the morning for 14 days | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: from Screening through Day 18
2 secondary outcomes
Dose linearity of CHF5074 plasma levels (Cmax)
Time frame: Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Time frame: Day -1 through Day 18
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 10 Feb 2015.
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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.
Magdy L Shenouda, MD principal investigator
Iberica Clinical Research Center
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 CHF5074 1x, CHF5074 2x and CHF5074 3x in people with Alzheimer's Disease, run by CERESPIR 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 1 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 10 Feb 2015. 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?
Adverse Events (time frame: from Screening through Day 18). 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 10 Feb 2015.