Postoperative PainPhase 1NCT04265456
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
A Phase 1 study testing Pregabalin 100mg and Acetaminophen 1300mg in people with Postoperative Pain, run by Nevakar, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin 100mg and Acetaminophen 1300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 22 Jul 2020
- 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
- Male or female aged 18 to 55 years, inclusive at time of Screening
- Body mass index (BMI) between 18.5 and 28.0 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG confirming normal sinus rhythm
- Negative tests for Hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening
- Routine clinical laboratory tests should be within normal limits at Screening and Admission (Day -1) or abnormalities deemed not clinically significant by the Investigator; for liver function tests, AST and ALT values should not be greater than 1.5 times the upper limit of normal range
- Negative screen for drugs of abuse or exhibit detectable alcohol levels by breathalyzer at the time of Screening or Admission
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- Non-smokers or ex-smokers (must have ceased smoking ≥3 months prior Screening visit)
- Female subjects:
- Must be of non-childbearing potential by surgical sterilization or postmenopausal OR Must not be pregnant, breast feeding, or planning to become pregnant AND must be practicing both a highly effective method of birth control from Screening until at least 90 days after the last dose of study drug.
- Women of childbearing potential must have a negative pregnancy test result at Screening and upon admission to the Clinical Trial Unit.
Who cannot join
- Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders
- Has a history of severe drug allergy, or severe hypersensitivity or severe food allergy, including anaphylaxis or known allergy or sensitivity to any component of PGB or APAP
- Has a history of alcoholism or drug abuse
- Has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) at the time of Screening or Admission
- Consumption of drugs with enzyme-inducing properties, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase
- Has used any prescription medicines, over the counter medicines, or herbal supplements, within 7 days of dosing
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- Has used any investigational product or participated in any clinical trial within 30 days prior to Screening
- Has donated or received any blood or blood products within the 3 months prior to Screening;
- Not able to comply with the requirements of this study, including assessments, duration of admission of the study and expected follow up visits
- Is unwilling or unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Resarch,LLC
Pasadena, California, 91105
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose (MTD) of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Up to 60 subjects will be enrolled into one (1) of six (6) sequential cohorts (n=10 per cohort [8 APAP + PGB and 2 placebo]).
The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg) based on Safety Monitoring Committee decision.
The placebo will be the saline solution.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin 100mg, Acetaminophen 1300mg
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 100mgDrug
Also called PGB
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
Acetaminophen 1300mgDrug
Also called Ofirmev
Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
| Study group | Role | What they receive |
|---|---|---|
| 1300 mg Acetaminophen and 100 mg IV Pregabalin | Experimental | The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg based on Safety Monitoring Committee decision). Receives: Drug: Pregabalin 100mg; Drug: Acetaminophen 1300mg |
| Placebo | No intervention | Saline solution |
| 1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin | Experimental | Decisions to escalate or decrease the dose for Cohorts 2 through 6 will be dependent upon blinded review of emerging safety and tolerability data by the Safety Monitoring Committee (SMC). However, PK data is not part of the SMC review, but may be reviewed by a SMC designee at a later time. Receives: Drug: Pregabalin 100mg; Drug: Acetaminophen 1300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Related Adverse Events
The incidence and severity of treatment-emergent adverse events
Measured: 7 days
Treatment related Drowsiness and Dizziness
The incidence and severity of somnolence and dizziness
Measured: 7 days
Secondary outcomes (19)
Plasma PK endpoints for APAP and PGB, SAD Phase, Cmax
Maximum observed concentration
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, Tmax
Time to maximum observed drug concentration (Tmax)
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, t1/2
Apparent elimination half-life
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-last
Area under the drug concentration-time curve from time zero to the last measurable concentration
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-inf
AUC from time zero to infinity
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, λz
Apparent terminal elimination rate constant
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, CL
Apparent clearance
Measured: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, Vz
Apparent terminal volume of distribution
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, AUCτ
Area under the plasma concentration-time curve during a dosage interval
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Tmax,ss
Time to Cmax at SS
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmax,ss
Maximum concentration at SS
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmin,ss
Minimum concentration at ss
Measured: 7 dyas
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cav,ss
Average plasma concentration at SS
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Vz, ss
Apparent volume of distribution at SS
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, CLss
Apparent total clearance at SS
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, λz,ss
Apparent first order terminal elimination rate constant at steady state
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, R
Accumulation index
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, LF
Linearity factor
Measured: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state
Fluctuation ratio
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start14 Jan 2020
- Primary completion15 Jun 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevakar, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265456
- Sponsor's protocol ID
- CP-NVK009-0004
- Status last verified
- Aug 2020
- First submitted
- 29 Jan 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04265456
- Acronym / sponsor ID
- CP-NVK009-0004
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nevakar, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- 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 is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose (MTD) of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Up to 60 subjects will be enrolled into one (1) of six (6) sequential cohorts (n=10 per cohort [8 APAP + PGB and 2 placebo]).
The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg) based on Safety Monitoring Committee decision.
The placebo will be the saline solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1300 mg Acetaminophen and 100 mg IV Pregabalin | Experimental | Drug: Pregabalin 100mg, Drug: Acetaminophen 1300mgThe dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg based on Safety Monitoring Committee decision). |
| Placebo | No intervention | –Saline solution |
| 1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin | Experimental | Drug: Pregabalin 100mg, Drug: Acetaminophen 1300mgDecisions to escalate or decrease the dose for Cohorts 2 through 6 will be dependent upon blinded review of emerging safety and tolerability data by the Safety Monitoring Committee (SMC). However, PK data is not part of the SMC review, but may be reviewed by a SMC designee at a later time. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female aged 18 to 55 years, inclusive at time of Screening
- Body mass index (BMI) between 18.5 and 28.0 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG confirming normal sinus rhythm
- Negative tests for Hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening
- Routine clinical laboratory tests should be within normal limits at Screening and Admission (Day -1) or abnormalities deemed not clinically significant by the Investigator; for liver function tests, AST and ALT values should not be greater than 1.5 times the upper limit of normal range
Key exclusion criteria (10 listed)
- Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders
- Has a history of severe drug allergy, or severe hypersensitivity or severe food allergy, including anaphylaxis or known allergy or sensitivity to any component of PGB or APAP
- Has a history of alcoholism or drug abuse
- Has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) at the time of Screening or Admission
- Consumption of drugs with enzyme-inducing properties, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase
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 |
|---|---|---|
| Pregabalin 100mgAlso: PGBPregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties. | Drug | 1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin, 1300 mg Acetaminophen and 100 mg IV Pregabalin |
| Acetaminophen 1300mgAlso: OfirmevAcetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. | Drug | 1300 mg Acetaminophen and 100 mg +/- 25 IV Pregabalin, 1300 mg Acetaminophen and 100 mg IV Pregabalin |
Primary outcome
Treatment Related Adverse Events
Time frame: 7 days
The incidence and severity of treatment-emergent adverse events
Treatment related Drowsiness and Dizziness
Time frame: 7 days
The incidence and severity of somnolence and dizziness
19 secondary outcomes
Plasma PK endpoints for APAP and PGB, SAD Phase, Cmax
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, Tmax
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, t1/2
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-last
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, AUC0-inf
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, λz
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, CL
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, SAD Phase, Vz
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, AUCτ
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Tmax,ss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmax,ss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cmin,ss
Time frame: 7 dyas
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Cav,ss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, Vz, ss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, CLss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, λz,ss
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, R
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state, LF
Time frame: 7 days
Plasma PK endpoints for APAP and PGB, multiple doses at steady state
Time frame: 7 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 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregabalin 100mg and Acetaminophen 1300mg in people with Postoperative Pain, run by Nevakar, 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 10 inclusion and 10 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 Aug 2020. 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?
Treatment Related Adverse Events (time frame: 7 days). The study lists 2 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 5 Aug 2020.