Bile Salt Export Pump (BSEP) TransporterPhase 4NCT04640571
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
A Phase 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is healthy, as determined by screening evaluation that is not greater than 60 days before the first study visit.
- Subject is male or female between 18 and 65 years of age, inclusive.
- Subject is an acceptable candidate for venipuncture.
- Subject is willing to stop all non-routine OTC medications, as well as vitamins, dietary supplements, and herbals, for 24 hours prior to study drug administration and during pharmacokinetic study visits.
Who cannot join
- Subject has a significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, renal, gastrointestinal, metabolic, or psychiatric).
- Subject has a clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of study drugs.
- Subject has a history of liver or gallbladder disease, or history of myopathy
- Subject has a history of angioedema either with or without previous treatment with an angiotensin converting enzyme inhibitor.
- Subject was previously diagnosed with diabetes, or treated with antidiabetic agents
- Subject has a history of alcohol or drug abuse, which in the opinion of the PI or medical physician, could jeopardize the subject's health or would compromise the subject's ability to participate in this trial.
Show all 16Show fewer
- Subject is pregnant, breast feeding, or trying to become pregnant.
- Female subject of childbearing potential is unwilling or unable to use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral birth control pill, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of patient or their partner(s), abstinence, or hormonal-based patches, ring, injections, and implants.
- Subject routinely uses (i.e. daily or weekly) prescription medication except hormonal birth control medication, routinely uses (i.e. daily or weekly) OTC medication, or routinely uses niacin to treat hypercholesterolemia. OTC medications do not include vitamins, dietary supplements, or herbals.
- Subject routinely uses (i.e. daily or weekly) acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti-nausea medication or other drugs that modulate GI function.
- Subject is currently taking metformin, valacyclovir, acyclovir, chenodiol, pravastatin, enalapril, enalaprilat, or medications known to interact with any of these medications.
- Subject has a history or allergy or sensitivity to metformin, valacyclovir, acyclovir, chenodiol, pravastatin, polysorbate 80, enalapril, enalaprilat, or history of any drug hypersensitivity or intolerance which, in the opinion of the PI or medical physician, would compromise the safety of the subject or the study.
- Subject has liver impairment as assessed by alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels greater than the upper limit of normal (ULN).
- Subject has renal impairment as assessed by creatinine clearance lower than 60mL/min/1.73m2, using the CKDEPI formula.
- Subject is not willing or able to be adherent to study protocol (e.g., study visits).
- Subject has a condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study employs two-sub-studies that share a common placebo arm.
The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt export pump (BSEP) in the liver, which excretes pravastatin and chenodeoxycholic acid from the liver into the bile.
The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir, chenodeoxycholic acid, and enalaprilat pharmacokinetics. We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine, which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 (PepT1) and apical sodium-bile acid transporter (ASBT), respectively. Enalaprilat is passively absorbed but with low permeability, and thus serves as a passive absorption reference.
- Being tested
- pravastatin and chenodeoxycholic acid, after metformin and placebo, valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo
- Keywords
- healthy volunteer, pharmacokinetics, excipient, transporter
- Medical subject headings
- Cholestasis, progressive familial intrahepatic 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatin and chenodeoxycholic acid, after metformin and placeboDrug
single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg
valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboDrug
single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo, then metformin, then polysorbate 80 | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
| metformin, then polysorbate 80, then placebo | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
| polysorbate 80, then placebo, then metformin | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
| polysorbate 80, then metformin, then placebo | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
| placebo, then polysorbate 80, then metformin | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
| metformin, then placebo, then polysorbate 80 | Experimental | Placebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day Receives: Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo; Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-Under-the-Curve (AUC) of Pravastatin After Metformin
Pravastatin AUC after metformin, compared to pravastatin AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Pravastatin After Metformin
Pravastatin Cmax after metformin, compared to pravastatin Cmax after placebo. Cmax units are concentration (i.e. ng/ml).
Measured: 0-10 hours
Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid After Metformin
Baseline-corrected chenodeoxycholic acid AUC after metformin. AUC Units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid After Metformin
Baseline-corrected chenodeoxycholic acid Cmax after metformin. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Measured: 0-10 hours
Area-Under-the-Curve (AUC) of Acyclovir After Polysorbate 80
Acyclovir AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Acyclovir After Polysorbate 80
Acyclovir Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml).
Measured: 0-10 hours
Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80
Baseline-corrected Chenodeoxycholic acid AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80
Baseline-corrected Chenodeoxycholic acid Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Measured: 0-10 hours
Area-Under-the-Curve (AUC) of Enalaprilat After Polysorbate 80
Enalaprilat AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Enalaprilat After Polysorbate 80
Enalaprilat Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml).
Measured: 0-10 hours
Secondary outcomes (4)
Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Polysorbate 80
For each of 15 endogenous bile acid, endogenous bile acid AUC after polysorbate 80, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Metformin
For each of 15 endogenous bile acid, endogenous bile acid Cmax after metformin, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml).
Measured: 0-10 hours
Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Metformin
For each of 15 endogenous bile acid, endogenous bile acid AUC after metformin, compared to endogenous bile acid AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h).
Measured: 0-10 hours
Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Polysorbate 80
For each of 15 endogenous bile acid, endogenous bile acid Cmax after polysorbate 80, compared to endogenous bile acid Cmax after placebo. Cmax units are concentration (i.e. ng/ml).
Measured: 0-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bile Salt Export Pump (BSEP) TransporterStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James E Polli, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640571
- Sponsor's protocol ID
- HP-00090086
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2020
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
- ClinicalTrials.gov ID
- NCT04640571
- Acronym / sponsor ID
- HP-00090086
- Keywords
- healthy volunteer, pharmacokinetics, excipient, transporter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study employs two-sub-studies that share a common placebo arm.
The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics. We hypothesize that metformin represses the bile salt export pump (BSEP) in the liver, which excretes pravastatin and chenodeoxycholic acid from the liver into the bile.
The objective of the other sub-study is to assess the impact of polysorbate 80 on valacyclovir, chenodeoxycholic acid, and enalaprilat pharmacokinetics. We hypothesize that polysorbate 80 inhibits uptake transporters in the intestine, which absorb valacyclovir and chenodeoxycholic acid in the gut via the peptide transporter 1 (PepT1) and apical sodium-bile acid transporter (ASBT), respectively. Enalaprilat is passively absorbed but with low permeability, and thus serves as a passive absorption reference.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| placebo, then metformin, then polysorbate 80 | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
| metformin, then polysorbate 80, then placebo | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
| polysorbate 80, then placebo, then metformin | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
| polysorbate 80, then metformin, then placebo | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
| placebo, then polysorbate 80, then metformin | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
| metformin, then placebo, then polysorbate 80 | Experimental | Drug: pravastatin and chenodeoxycholic acid, after metformin and placebo, Drug: valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placeboPlacebo is one twice a day, metformin is 500mg twice a day, and polysorbate 80 is 400mg twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is healthy, as determined by screening evaluation that is not greater than 60 days before the first study visit.
- Subject is male or female between 18 and 65 years of age, inclusive.
- Subject is an acceptable candidate for venipuncture.
- Subject is willing to stop all non-routine OTC medications, as well as vitamins, dietary supplements, and herbals, for 24 hours prior to study drug administration and during pharmacokinetic study visits.
Key exclusion criteria (16 listed)
- Subject has a significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, renal, gastrointestinal, metabolic, or psychiatric).
- Subject has a clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of study drugs.
- Subject has a history of liver or gallbladder disease, or history of myopathy
- Subject has a history of angioedema either with or without previous treatment with an angiotensin converting enzyme inhibitor.
- Subject was previously diagnosed with diabetes, or treated with antidiabetic agents
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 |
|---|---|---|
| pravastatin and chenodeoxycholic acid, after metformin and placebosingle oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg | Drug | metformin, then placebo, then polysorbate 80, metformin, then polysorbate 80, then placebo, placebo, then metformin, then polysorbate 80, placebo, then polysorbate 80, then metformin, polysorbate 80, then metformin, then placebo, polysorbate 80, then placebo, then metformin |
| valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebosingle oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg | Drug | metformin, then placebo, then polysorbate 80, metformin, then polysorbate 80, then placebo, placebo, then metformin, then polysorbate 80, placebo, then polysorbate 80, then metformin, polysorbate 80, then metformin, then placebo, polysorbate 80, then placebo, then metformin |
Primary outcome
Area-Under-the-Curve (AUC) of Pravastatin After Metformin
Time frame: 0-10 hours
Pravastatin AUC after metformin, compared to pravastatin AUC after placebo. AUC units are concentration x time (i.e. ng/ml x h).
Peak Plasma Concentration (Cmax) of Pravastatin After Metformin
Time frame: 0-10 hours
Pravastatin Cmax after metformin, compared to pravastatin Cmax after placebo. Cmax units are concentration (i.e. ng/ml).
Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid After Metformin
Time frame: 0-10 hours
Baseline-corrected chenodeoxycholic acid AUC after metformin. AUC Units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid After Metformin
Time frame: 0-10 hours
Baseline-corrected chenodeoxycholic acid Cmax after metformin. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Area-Under-the-Curve (AUC) of Acyclovir After Polysorbate 80
Time frame: 0-10 hours
Acyclovir AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h).
Peak Plasma Concentration (Cmax) of Acyclovir After Polysorbate 80
Time frame: 0-10 hours
Acyclovir Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml).
Area-Under-the-Curve (AUC) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80
Time frame: 0-10 hours
Baseline-corrected Chenodeoxycholic acid AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Peak Plasma Concentration (Cmax) of Chenodeoxycholic Acid (CDCA) After Polysorbate 80
Time frame: 0-10 hours
Baseline-corrected Chenodeoxycholic acid Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml). Baseline-corrected chenodeoxycholic acid is chenodeoxycholic acid concentration minus chenodeoxycholic acid concentration value at time zero (i.e. t=0).
Area-Under-the-Curve (AUC) of Enalaprilat After Polysorbate 80
Time frame: 0-10 hours
Enalaprilat AUC after polysorbate 80. AUC units are concentration x time (i.e. ng/ml x h).
Peak Plasma Concentration (Cmax) of Enalaprilat After Polysorbate 80
Time frame: 0-10 hours
Enalaprilat Cmax after polysorbate 80. Cmax units are concentration (i.e. ng/ml).
4 secondary outcomes
Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Polysorbate 80
Time frame: 0-10 hours
Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Metformin
Time frame: 0-10 hours
Area-Under-the-Curve (AUC) of Endogenous Bile Acids After Metformin
Time frame: 0-10 hours
Peak Plasma Concentration (Cmax) of Endogenous Bile Acids After Polysorbate 80
Time frame: 0-10 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 4 study of Bile Salt Export Pump (BSEP) Transporter and Polysorbate 80, run by University of Maryland, Baltimore 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 16 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 16 Jul 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area-Under-the-Curve (AUC) of Pravastatin After Metformin (time frame: 0-10 hours). The study lists 10 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 16 Jul 2024.