Pharmacokinetic Assessments in Healthy VolunteersPhase 1NCT01786382
A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole
A Phase 1 study testing PPI-668, Midazolam and Omeprazole in people with Pharmacokinetic Assessments in Healthy Volunteers, run by Presidio Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary objectives of the study are to: Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Assessments in Healthy Volunteers
- What is being tested?
- PPI-668, Midazolam and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject or legally authorized representative signs an Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for sites in the United States) before any study-related procedures (including withdrawal of prohibited medication, if applicable) are performed
- Age 18 to 50 years
- Body mass index (BMI) 18-32 kg/m2
- Clinical and laboratory findings consistent with good health in the opinion of the investigator
- Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study
- Women of non-childbearing potential must be one of the following:
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- Postmenopausal (>2 years amenorrhea and postmenopausal status confirmed by follicle-stimulating hormone levels)
- Surgically sterile (documentation of prior tubal ligation, hysterectomy, or oophorectomy is required)
- Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:
- Double-barrier contraceptive (e.g., condom plus diaphragm, condom or diaphragm with spermicidal gel/foam)
- Female partner is at least two years postmenopausal or surgically sterile
Who cannot join
- Positive results on any of the following tests at Screening or Day -1:
- urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
- Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
- Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
- Clinically significant illness within 30 days preceding entry into the study
- Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening
- Use of prescription medications within 14 days before Day 1 and throughout the study. (The use of non-prescription or over-the-counter medications is prohibited within 7 days before Day 1 and throughout the study. This includes all herbal supplements or remedies and vitamins.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Potential Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole, and Potentially Telaprevir, in Healthy Adult Subjects
The primary objectives of the study are to:
- Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects.
- Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject
- Being tested
- PPI-668, Midazolam, Omeprazole, Telaprevir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI-668Drug
MidazolamDrug
OmeprazoleDrug
TelaprevirDrug
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Experimental | potential effects of PPI-668 on midazolam pharmacokinetics Receives: Drug: PPI-668; Drug: Midazolam |
| omeprazole | Experimental | potential effects of PPI-668 on omeprazole pharmacokinetics Receives: Drug: PPI-668; Drug: Omeprazole |
| telaprevir | Experimental | potential effects of PPI-668 on telaprevir pharmacokinetics Receives: Drug: PPI-668; Drug: Telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Measured: Days 1-6
Midazolam maximum observed plasma concentration (Cmax)
Measured: Days 1-6
Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Measured: Days 1-6
Omeprazole maximum observed plasma concentration (Cmax)
Measured: Days 1-6
Secondary outcomes (2)
Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Measured: Days 1-12
Telaprevir maximum observed plasma concentration (Cmax)
Measured: Days 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 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
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Paul Rice, MD, Principal investigator, Spaulding Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786382
- Sponsor's protocol ID
- PPI-668-102
- Status last verified
- Mar 2013
- First submitted
- 4 Feb 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Potential Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole, and Potentially Telaprevir, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01786382
- Acronym / sponsor ID
- PPI-668-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Presidio Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Feb 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.
The primary objectives of the study are to:
- Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects.
- Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam | Experimental | Drug: PPI-668, Drug: Midazolampotential effects of PPI-668 on midazolam pharmacokinetics |
| omeprazole | Experimental | Drug: PPI-668, Drug: Omeprazolepotential effects of PPI-668 on omeprazole pharmacokinetics |
| telaprevir | Experimental | Drug: PPI-668, Drug: Telaprevirpotential effects of PPI-668 on telaprevir pharmacokinetics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject or legally authorized representative signs an Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for sites in the United States) before any study-related procedures (including withdrawal of prohibited medication, if applicable) are performed
- Age 18 to 50 years
- Body mass index (BMI) 18-32 kg/m2
- Clinical and laboratory findings consistent with good health in the opinion of the investigator
- Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study
Key exclusion criteria (7 listed)
- Positive results on any of the following tests at Screening or Day -1:
- urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
- Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
- Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
- Clinically significant illness within 30 days preceding entry into the study
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 | Drug | midazolam, omeprazole, telaprevir |
| Midazolam | Drug | midazolam |
| Omeprazole | Drug | omeprazole |
| Telaprevir | Drug | telaprevir |
Primary outcome
Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-6
Midazolam maximum observed plasma concentration (Cmax)
Time frame: Days 1-6
Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-6
Omeprazole maximum observed plasma concentration (Cmax)
Time frame: Days 1-6
2 secondary outcomes
Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-12
Telaprevir maximum observed plasma concentration (Cmax)
Time frame: Days 1-12
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 26 Mar 2013.
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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.
Paul Rice, MD principal investigator
Spaulding Clinical
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, Midazolam and Omeprazole 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 11 inclusion and 7 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 26 Mar 2013. 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?
Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24) (time frame: Days 1-6). The study lists 4 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 26 Mar 2013.