Pharmacokinetic Assessments in Healthy VolunteersPhase 1NCT01979484
Phase 1 Study of Relative Bioavailability of PPI-668 Tablet and Capsule Formulations
A Phase 1 study testing PPI-668 capsule and PPI-668 tablet in people with Pharmacokinetic Assessments in Healthy Volunteers, run by Presidio Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Assessments in Healthy Volunteers
- What is being tested?
- PPI-668 capsule and PPI-668 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Must be between 18 and 55 years of age, inclusive.
- Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
- Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
- Must be HIV-1 antibody negative.
- Must be hepatitis B (HBV) surface antigen negative.
- Must be hepatitis C (HCV) antibody negative.
Who cannot join
- Pregnant or lactating subjects.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- Have poor venous access and unable to donate blood.
- Have donated blood within 56 days of study dosing.
- Have donated plasma within 7 days of study dosing.
- Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Clinical Research Center
Buffalo, New York, 14202
About this study
Official title: A Phase 1, Open-Label, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.
- Being tested
- PPI-668 capsule, PPI-668 tablet
- Keywords
- bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-668 capsuleDrug
PPI-668 tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| PPI-668 capsule followed by tablet | Experimental | On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered Receives: Drug: PPI-668 capsule; Drug: PPI-668 tablet |
| PPI-668 tablet followed by capsule | Experimental | On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered Receives: Drug: PPI-668 capsule; Drug: PPI-668 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
Measured: Days 1 - 8
PPI-668 maximum observed plasma concentration (Cmax)
Measured: Days 1 - 8
PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
Measured: Days 1 - 8
Secondary outcomes (2)
number of participants with adverse events
Measured: Days 1 - 8
number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels
Measured: Days 1 - 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic Assessments in Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathaniel Brown, MD, Study director, Presidio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979484
- Sponsor's protocol ID
- PPI-668-103
- Status last verified
- Jan 2014
- First submitted
- 28 Oct 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01979484
- Acronym / sponsor ID
- PPI-668-103
- Keywords
- bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Nov 2013 (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.
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI-668 capsule followed by tablet | Experimental | Drug: PPI-668 capsule, Drug: PPI-668 tabletOn day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered |
| PPI-668 tablet followed by capsule | Experimental | Drug: PPI-668 capsule, Drug: PPI-668 tabletOn day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- Must be between 18 and 55 years of age, inclusive.
- Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
- Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
- Must be HIV-1 antibody negative.
Key exclusion criteria (8 listed)
- Pregnant or lactating subjects.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- Have poor venous access and unable to donate blood.
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 |
|---|---|---|
| PPI-668 capsule | Drug | PPI-668 capsule followed by tablet, PPI-668 tablet followed by capsule |
| PPI-668 tablet | Drug | PPI-668 capsule followed by tablet, PPI-668 tablet followed by capsule |
Primary outcome
PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
Time frame: Days 1 - 8
PPI-668 maximum observed plasma concentration (Cmax)
Time frame: Days 1 - 8
PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
Time frame: Days 1 - 8
2 secondary outcomes
number of participants with adverse events
Time frame: Days 1 - 8
number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels
Time frame: Days 1 - 8
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 9 Jan 2014.
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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.
Nathaniel Brown, MD study director
Presidio 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 PPI-668 capsule and PPI-668 tablet in people with Pharmacokinetic Assessments in Healthy Volunteers, run by Presidio 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 7 inclusion and 8 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 9 Jan 2014. 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?
PPI-668 area under the curve from time zero to infinity (AUC 0-inf) (time frame: Days 1 - 8). The study lists 3 primary outcomes in all. 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 9 Jan 2014.