HealthyPhase 1NCT02725112
Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers
A Phase 1 study testing Pregabalin ER in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2016to 17 Jun 2016
- 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
- Healthy female subjects and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests. A 1:1 ratio of men to women is desirable, but it will not be considered a protocol deviation if this is not met.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of febrile illness within 5 days prior to the first dose of study investigational product.
- Subjects with an estimated CLcr <60 mL/min derived using the method of Crockcroft and Gault.1
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
Show all 19Show fewer
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
- Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study investigational product (whichever is longer).
- Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure is >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), the blood pressure should be repeated 2 more times and the average of the 3 blood pressure values should be used to determine the subject's eligibility.
- Screening supine 12 lead ECG demonstrating QTc (time from ECG Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for the heart rate) >450 msec or a QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- Use of prescription (other than oral, transdermal, intrauterine, implanted, or injected contraceptives or hormone replacement therapy) or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.investigational product. Herbal supplements must be discontinued at least 28 days prior to the first dose of study medicationinvestigational product. As an exception, acetaminophen/paracetamol may be used at doses of greater than 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the Sponsor.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of sensitivity to pregabalin, gabapentin, or other alpha2 delta ligands.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Previous participation in a study involving pregabalin.
- Subjects who are investigational site staff members directly involved in the study, their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Open-label, Single-dose, 6-period Study To Investigate The Effect Of In Vitro Dissolution Rate On The In Vivo Bioavailability Of Extended Release Formulations Of Pregabalin In Healthy Volunteers
This study is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be replaced at the Sponsor's discretion. Screening activities will be completed within approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6 treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6 periods with subjects receiving single doses of pregabalin ER 330 mg target release rate tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments will be administered following a 600- 750 calorie, 30% fat evening meal.
- Conditions
- Healthy
- Being tested
- Pregabalin ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin ERDrug
A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.
Pregabalin ERDrug
B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.
Pregabalin ERDrug
C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.
Pregabalin ERDrug
D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.
Pregabalin ERDrug
E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.
Pregabalin ERDrug
F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin ER- Target Release 330mg | Experimental | A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral. Receives: Drug: Pregabalin ER |
| Pregabalin ER - Slow Release 330mg | Experimental | B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral. Receives: Drug: Pregabalin ER |
| Pregabalin ER - Fast Release 330mg | Experimental | C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral. Receives: Drug: Pregabalin ER |
| Pregabalin IR - 300mg | Experimental | D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral. Receives: Drug: Pregabalin ER |
| Pregabalin ER - Target Release 82.5mg | Experimental | E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral. Receives: Drug: Pregabalin ER |
| Pregabalin ER - Aberrant Fast 330mg | Experimental | F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral. Receives: Drug: Pregabalin ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax from time zero to infinity (AUCinf), when data permits, otherwise AUC from time zero to last quantifiable concentration (AUClast) of pregabalin ER 330 mg slow and fast release rate tablet formulations.
To evaluate the relative bioavailability of pregabalin ER 330 mg slow and fast release rate tablet formulations administered immediately following an evening meal.
Measured: 10 week Study Duration
AUC from time zero to infinity (AUCinf), when data permits, otherwise AUC from time zero to last quantifiable concentration (AUClast) of pregabalin ER 330 mg slow and fast release rate tablet formulations.
To evaluate the relative bioavailability of pregabalin ER 330 mg slow and fast release rate tablet formulations administered immediately following an evening meal
Measured: 10 week Study Duration
Secondary outcomes (6)
Cmax of pregabalin.
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
Time to Cmax (Tmax) of pregabalin
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
Lag time (Tlag) of pregabalin
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
AUC of pregabalin
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
Terminal elimination half life (t½) of pregabalin
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
Safety endpoints include evaluation of AEs.
To evaluate the PK, safety and tolerability of single doses of pregabalin IR (300 mg) capsule formulation and pregabalin ER (82.5 and 330 mg) tablet formulations in healthy volunteers.
Measured: 10 week study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start12 Feb 2016
- Primary completion22 May 2016
- Study completion17 Jun 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725112
- Sponsor's protocol ID
- A0081309
- Status last verified
- Jun 2017
- First submitted
- 10 Feb 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Single-dose, 6-period Study To Investigate The Effect Of In Vitro Dissolution Rate On The In Vivo Bioavailability Of Extended Release Formulations Of Pregabalin In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02725112
- Acronym / sponsor ID
- A0081309
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 22 May 2016 (actual)
- Study completion
- 17 Jun 2016 (actual)
- First posted
- 31 Mar 2016 (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 is a Phase 1, randomized, open label, single dose, 6 treatment, 6 period, 6 sequence study in healthy adult volunteers. A total of 24 (4 in each treatment sequence) healthy male and female subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive will be enrolled. Subjects who discontinue from the study may be replaced at the Sponsor's discretion. Screening activities will be completed within approximately 28 days prior to Day 1 of Period 1. Subjects will be randomized to 1 of the 6 treatment sequences as described in Table 1 below. Each treatment sequence will consist of 6 periods with subjects receiving single doses of pregabalin ER 330 mg target release rate tablet, pregabalin ER 330 mg slow release rate tablet, pregabalin ER 330 mg fast release rate tablet, pregabalin IR 300 mg capsule, pregabalin ER 82.5 mg target release rate tablet, and pregabalin ER 330 mg aberrant fast release rate tablet formulations. All study treatments will be administered following a 600- 750 calorie, 30% fat evening meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pregabalin ER- Target Release 330mg | Experimental | Drug: Pregabalin ERA: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral. |
| Pregabalin ER - Slow Release 330mg | Experimental | Drug: Pregabalin ERB: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral. |
| Pregabalin ER - Fast Release 330mg | Experimental | Drug: Pregabalin ERC: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral. |
| Pregabalin IR - 300mg | Experimental | Drug: Pregabalin ERD: Pregabalin IR capsule formulation, 1 x 300 mg, Oral. |
| Pregabalin ER - Target Release 82.5mg | Experimental | Drug: Pregabalin ERE: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral. |
| Pregabalin ER - Aberrant Fast 330mg | Experimental | Drug: Pregabalin ERF: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests. A 1:1 ratio of men to women is desirable, but it will not be considered a protocol deviation if this is not met.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (19 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of febrile illness within 5 days prior to the first dose of study investigational product.
- Subjects with an estimated CLcr <60 mL/min derived using the method of Crockcroft and Gault.1
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
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 ERA: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral. | Drug | Pregabalin ER- Target Release 330mg |
| Pregabalin ERB: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral. | Drug | Pregabalin ER - Slow Release 330mg |
| Pregabalin ERC: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral. | Drug | Pregabalin ER - Fast Release 330mg |
| Pregabalin ERD: Pregabalin IR capsule formulation, 1 x 300 mg, Oral. | Drug | Pregabalin IR - 300mg |
| Pregabalin ERE: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral. | Drug | Pregabalin ER - Target Release 82.5mg |
| Pregabalin ERF: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral. | Drug | Pregabalin ER - Aberrant Fast 330mg |
Primary outcome
Cmax from time zero to infinity (AUCinf), when data permits, otherwise AUC from time zero to last quantifiable concentration (AUClast) of pregabalin ER 330 mg slow and fast release rate tablet formulations.
Time frame: 10 week Study Duration
To evaluate the relative bioavailability of pregabalin ER 330 mg slow and fast release rate tablet formulations administered immediately following an evening meal.
AUC from time zero to infinity (AUCinf), when data permits, otherwise AUC from time zero to last quantifiable concentration (AUClast) of pregabalin ER 330 mg slow and fast release rate tablet formulations.
Time frame: 10 week Study Duration
To evaluate the relative bioavailability of pregabalin ER 330 mg slow and fast release rate tablet formulations administered immediately following an evening meal
6 secondary outcomes
Cmax of pregabalin.
Time frame: 10 week study duration
Time to Cmax (Tmax) of pregabalin
Time frame: 10 week study duration
Lag time (Tlag) of pregabalin
Time frame: 10 week study duration
AUC of pregabalin
Time frame: 10 week study duration
Terminal elimination half life (t½) of pregabalin
Time frame: 10 week study duration
Safety endpoints include evaluation of AEs.
Time frame: 10 week 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 20 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
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 ER in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris 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 4 inclusion and 19 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 20 Jan 2021. 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?
Cmax from time zero to infinity (AUCinf), when data permits, otherwise AUC from time zero to last quantifiable concentration (AUClast) of pregabalin ER 330 mg slow and fast release rate tablet formulations. (time frame: 10 week Study Duration). 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 20 Jan 2021.