Healthy VolunteersPhase 1NCT04725682
Bioequivalence Study of Tacrolimus in Healthy Volunteers
A Phase 1 study testing Tacrolimus in people with Healthy Volunteers, run by Food and Drug Administration (FDA) at 1 site in United States.
Trial summary
This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 17 Jun 2021
- Phase
- Phase 1
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and female volunteers, 18 -59 years of age (inclusive).
- BMI that is within 18.5-33.0 kg/m², inclusive.
- Healthy, according to medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Capable of giving written informed consent prior to receiving any study medication.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Smokers: Capable of refraining from smoking for the duration of the confinement.
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- Female subjects must be non-pregnant, non-lactating and fulfill at least one of the following:
- Be surgically sterile for a minimum of 6 months
- Post-menopausal for a minimum of 12 months; Menopause defined as 12 months of amenorrhea without any other obvious pathological or physiological cause.
- Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).
- Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (foam or vaginal spermicidal suppository in conjunction with a male condom, diaphragm with spermicide in conjunction with a male condom). Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
- If a female subject becomes pregnant during participation in the study or within 30 days after she has completed her last tacrolimus administration (whichever was administered last), she must inform BPSUSA staff immediately.
- Males who are able to father children must agree to use medically acceptable methods of contraception and not to donate sperm during the study and for 30 days after the end of the study.
- Medically acceptable methods of contraception include using a condom with a female partner of child-bearing potential who is using: oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicide.
- If a male subject's partner becomes pregnant during his participation in the study or within 30 days after he has completed his last tacrolimus administration (whichever was administered last), he must inform BPSUSA staff immediately.
Who cannot join
- Known history and/or presence of any clinically significant hepatic (e.g., hepatitis, jaundice, hepatic failure, hepatic necrosis, hepatic encephalopathy, biliary tract diseases, cirrhosis), renal/genitourinary (e.g., urethral stricture, any renal impairment), gastrointestinal, cardiovascular (e.g., hypotension including orthostatic hypotension, cor pulmonale, congenital long QT, congestive heart failure, bradyarrhythmias), cerebrovascular, pulmonary (e.g., chronic obstructive pulmonary disease, decreased respiratory reserve, hypoxia, pre-existing respiratory depression), endocrine (e.g., myxedema, hypothyroidism, adrenal cortical insufficiency), immunological, musculoskeletal (e.g., kyphoscoliosis), neurological (e.g., CNS depression or coma, increased cerebrospinal pressure), psychiatric (e.g., psychosis, depression, hallucinations, delirium tremens, suicidal thoughts or behavior), dermatological or hematological (e.g., thrombocytopenic purpura) disease or condition unless determined as not clinically significant by the PI/Sub- Investigator.
- History or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first tacrolimus administration, as determined by the PI/Sub-Investigator.
- Systolic blood pressure outside 90-130 mmHg, inclusive, and diastolic blood pressure outside 55-80 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- QTc interval ≥ 440 milliseconds for males and ≥ 460 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator.
- Abnormal clinical laboratory values unless values are deemed by the PI/Sub- Investigator as "Not Clinically Significant".
- Abnormal vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR], pulse oximetry and temperature) measurements, unless deemed otherwise by the PI/Sub-Investigator.
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- Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
- Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
- A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), and alcohol test. Positive serum or urine pregnancy test for female subjects.
- Known history or presence of:
- Alcohol abuse or dependence within one year prior to first study drug administration;
- Drug abuse or dependence;
- Hypersensitivity or idiosyncratic reaction to tacrolimus, its excipients, and/or related substances;
- Lymphoma and other malignancies (particularly of the skin);
- Bacterial, viral, fungal and protozoal infections (e.g., polyoma virus- associated nephropathy [PVAN] due to BK virus infection, JC virus associated progressive multifocal leukoencephalopathy [PML], Epstein Barr Virus (EBC) associated Post transplant lymphoproliferative disorder [PTLD], cytomegalovirus (CMV) infections associated CMV viremia and CMV disease);
- Tuberculosis;
- Posterior reversible encephalopathy syndrome (PRES);
- Pure red cell aplasia (PRCA);
- Gastrointestinal perforation;
- Hyperkalemia;
- Hypertension;
- Lactose intolerance, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- Food allergies and/or presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant".
- Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
- History of intolerance to and/or difficulty with blood sampling through venipuncture.
- Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets, vegan, etc.
- Individuals who have donated, in the days prior to first tacrolimus administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL or more or double red blood cell ("Power red") donation in the previous 56 days.
- Donation of plasma by plasmapheresis within 7 days prior to first tacrolimus administration.
- Hemoglobin level of 12.0 g/dL or lower.
- Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first tacrolimus administration.
- Not being able to fast for at least 14 hours.
- Consumption of food or beverages containing grapefruit and/or pomelo within 3 days prior to first study drug administration.
- Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing in each study period.
- Use of any prescription medication within 14 days prior to first tacrolimus administration (except for allowed contraceptive products).
- Use of any over-the-counter medications (including low-dose aspirin, oral multivitamins, allergy medications, herbal and/or dietary supplements) within 14 days prior to first tacrolimus administration (except for spermicidal/barrier contraceptive products).
- Use of any enzyme-modifying drugs and/or other products, including inhibitors of cytochrome P450 (CYP) enzymes such as antifungals (e.g., ketoconazole, itraconazole, fluconazole, voriconazole, posaconazole, clotrimazole), macrolide antibiotics (e.g., erythromycin, clarithromycin, josamycin), protease inhibitors (e.g., ritonavir, telaprevir [IncivekTM], boceprevir [VictrelisTM], nelfinavir [Viracept®], saquinavir), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine, nicardipine), nucleotide reverse transcriptase inhibitors (e.g., tenofovir), gastric acid, suppressors/neturalizers (e.g., lansoprazole, omeprazole, cimetidine, cisapride, magnesium-aluminum hydroxide antacids), bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, quinidine, tamoxifen, and triacetyl- oleandomycin and inducers of CYP enzymes such as anti-myobacterials (e.g., rifampin, rifabutin), antifungal agent (e.g., caspofungin), anticonvulsants (e.g. phenytoin, carbamazepine, phenobarbital), corticosteroids (e.g. prednisolone or methylprednisolone), metamizole, isoniazid and products containing St. John's Wort in the previous 30 days before first study drug administration.
- Use of medicines such as, mycophenolic acid (MPA) products, aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, oral anticoagulants, or oral antidiabetics, ganciclovir, acyclovir, amphotericin B, ibuprofen, cisplatin, potassium supplements, potassium- sparing diuretics (e.g., amiloride, triamterene or spironolactone), ACE inhibitors (for example, benazepril, enalapril, quinapril), statins (for example, atorvastatin, fluvastatin, simvastatin), angiotensin receptor blockers (for example, irbesartan, valsartan, azilsartan), nefazodone, metoclopramide, danazol, and herbal products containing Schisandra sphenanthera extracts should be avoided during treatment with tacrolimus in the previous 30 days before first study drug administration.
- Use of any QT prolonging drugs (e.g., citalopram, chlorpromazine, haloperidol, methadone), amiodarone [CordaroneTM, NexteroneTM, PaceroneTM], immunosuppressive or immunomodulating therapies (e.g. sirolimus [Rapamune®], cyclosporins [Gengraf®, Neoral®, and Sandimune®], antilymphocytic antibodies [e.g., basiliximab, daclizumab]) should be avoided during treatment with tacrolimus in the previous 30 days before first study drug administration.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by PI/Sub-Investigator.
- Does not agree, to refrain from driving or operating heavy machinery if feeling dizzy or drowsy following tacrolimus administration until full mental alertness is regained.
- Does not have an ability to fast for at least 14 hours.
- Recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence of tuberculosis.
- Temperature at visit is ≥ 100.4 F° (38.0°C).
- Test positive for SARS-CoV-2 by locally available, verified test.
- Have had common symptoms of COVID-19 currently or in the past 14 days as documented in the COVID-19 screening questionnaire and symptom checklist
- Have had an exposure to suspected or confirmed cases of COVID-19 in the past two weeks as documented in the COVID-19 screening questionnaire
- Recent live attenuated vaccine1 recipients in the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Open-Label, Randomized, Four-Way Crossover, Fully Replicate, Bioequivalence Study of Generic Tacrolimus and Prograf® Capsules in Healthy Volunteers Under Fasting Conditions
This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions. The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.
Read the detailed description
This is a single-dose, randomized, open-label, fully replicate crossover, four-period, two- treatment, two-sequence, bioequivalence study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD).
Tacrolimus, a calcineurin inhibitor (CNI), has been widely used in solid organ and bone marrow transplants for more than two decades. Calcineurin, a calcium-dependent phosphatase, is instrumental for signal transduction for activation of T cell and B cell, which in turn cause production of autoinflammatory cytokines such as such as interleukin 2 (IL- 2), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ). CNIs prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB), thereby inhibiting the signal transduction responsible for growth and proliferation of activated T cells and expression of autoinflammatory cytokines. This mechanism of action results in immunosuppression and prevents organ rejection.
However, therapeutic drug monitoring is required for tacrolimus since the range between tacrolimus therapeutic and toxic tacrolimus whole blood concentrations is narrow and some toxicities are serious and/or irreversible. The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions.
The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.
- Conditions
- Healthy Volunteers
- Being tested
- Tacrolimus
- Keywords
- generic drug, tacrolimus, bioequivalence, reference listed drug, fasting condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
a single dose of 1 mg capsule per period
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (TRTR) | Active comparator | Each subject is scheduled to receive each treatment twice by the end of the study in the order of TRTR.
Treatment T (Test): 1 × 1mg Test tacrolimus capsules (Applicant holder: Accord Healthcare, Inc.); Treatment R (Reference): 1 × 1mg RLD tacrolimus capsules Receives: Drug: Tacrolimus |
| Sequence 2 (RTRT) | Active comparator | Each subject is scheduled to receive each treatment twice by the end of the study in the order of RTRT.
Treatment T (Test): 1 × 1mg Test tacrolimus capsules (Applicant holder: Accord Healthcare, Inc.); Treatment R (Reference): 1 × 1mg RLD capsules Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration (AUC 72)
Measurement of whole blood tacrolimus prior to dosing and up to 72 hours post-dose
Measured: 72 hours
Maximum Plasma Concentration (Cmax)
Measurement of whole blood tacrolimus prior to dosing and up to 144 hours post-dose
Measured: 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 hours
Secondary outcomes (3)
Time at Maximum Plasma Concentration (Tmax)
Measurement of whole blood tacrolimus prior to dosing and up to 144 hours post-dose
Measured: 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 hours
Area Under the Concentration (AUC Inf)
Time curve from time zero to infinity, calculated as AUCt + Clast/λ, where Clast is the last measurable concentration. Measurement of whole blood tacrolimus prior to dosing and up to 144 hours post-dose.
Measured: Estimated using the last measurable concentration (144 hours)
Area Under the Concentration (AUC 0-t)
Area under the concentration-time curve from time zero until the last measurable concentration or last sampling time t, whichever occurs first.
Measured: To the last measurable concentration or last sampling time t, whichever occurs first. (0 to 144 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start5 Jan 2021
- Primary completion14 May 2021
- Study completion17 Jun 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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a single-dose, randomized, open-label, four-period, two-sequence, two- treatment, single-center, crossover, bioequivalence study
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- BioPharma Services Inc.
- Responsible party
- Sponsor
- Investigators
- Artan Markollari, MD, Principal investigator, BioPharma Services Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725682
- Sponsor's protocol ID
- Protocol 2521
- Status last verified
- Sep 2023
- First submitted
- 15 Jan 2021
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan is to make the deidentified, participant data that underlie the results reported in a publication available to researchers who provide a methodologically sound proposal. In addition, the protocol will be made available online at this registry.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open-Label, Randomized, Four-Way Crossover, Fully Replicate, Bioequivalence Study of Generic Tacrolimus and Prograf® Capsules in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04725682
- Acronym / sponsor ID
- Protocol 2521
- Conditions
- Healthy Volunteers
- Keywords
- generic drug, tacrolimus, bioequivalence, reference listed drug, fasting condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- BioPharma Services Inc.
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions. The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.
Detailed description
This is a single-dose, randomized, open-label, fully replicate crossover, four-period, two- treatment, two-sequence, bioequivalence study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD).
Tacrolimus, a calcineurin inhibitor (CNI), has been widely used in solid organ and bone marrow transplants for more than two decades. Calcineurin, a calcium-dependent phosphatase, is instrumental for signal transduction for activation of T cell and B cell, which in turn cause production of autoinflammatory cytokines such as such as interleukin 2 (IL- 2), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ). CNIs prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB), thereby inhibiting the signal transduction responsible for growth and proliferation of activated T cells and expression of autoinflammatory cytokines. This mechanism of action results in immunosuppression and prevents organ rejection.
However, therapeutic drug monitoring is required for tacrolimus since the range between tacrolimus therapeutic and toxic tacrolimus whole blood concentrations is narrow and some toxicities are serious and/or irreversible. The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions.
The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a single-dose, randomized, open-label, four-period, two-sequence, two- treatment, single-center, crossover, bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (TRTR) | Active comparator | Drug: TacrolimusEach subject is scheduled to receive each treatment twice by the end of the study in the order of TRTR. Treatment T (Test): 1 × 1mg Test tacrolimus capsules (Applicant holder: Accord Healthcare, Inc.); Treatment R (Reference): 1 × 1mg RLD tacrolimus capsules |
| Sequence 2 (RTRT) | Active comparator | Drug: TacrolimusEach subject is scheduled to receive each treatment twice by the end of the study in the order of RTRT. Treatment T (Test): 1 × 1mg Test tacrolimus capsules (Applicant holder: Accord Healthcare, Inc.); Treatment R (Reference): 1 × 1mg RLD capsules |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males and female volunteers, 18 -59 years of age (inclusive).
- BMI that is within 18.5-33.0 kg/m², inclusive.
- Healthy, according to medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
- Capable of giving written informed consent prior to receiving any study medication.
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
Key exclusion criteria (49 listed)
- Known history and/or presence of any clinically significant hepatic (e.g., hepatitis, jaundice, hepatic failure, hepatic necrosis, hepatic encephalopathy, biliary tract diseases, cirrhosis), renal/genitourinary (e.g., urethral stricture, any renal impairment), gastrointestinal, cardiovascular (e.g., hypotension including orthostatic hypotension, cor pulmonale, congenital long QT, congestive heart failure, bradyarrhythmias), cerebrovascular, pulmonary (e.g., chronic obstructive pulmonary disease, decreased respiratory reserve, hypoxia, pre-existing respiratory depression), endocrine (e.g., myxedema, hypothyroidism, adrenal cortical insufficiency), immunological, musculoskeletal (e.g., kyphoscoliosis), neurological (e.g., CNS depression or coma, increased cerebrospinal pressure), psychiatric (e.g., psychosis, depression, hallucinations, delirium tremens, suicidal thoughts or behavior), dermatological or hematological (e.g., thrombocytopenic purpura) disease or condition unless determined as not clinically significant by the PI/Sub- Investigator.
- History or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first tacrolimus administration, as determined by the PI/Sub-Investigator.
- Systolic blood pressure outside 90-130 mmHg, inclusive, and diastolic blood pressure outside 55-80 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
- QTc interval ≥ 440 milliseconds for males and ≥ 460 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator.
- Abnormal clinical laboratory values unless values are deemed by the PI/Sub- Investigator as "Not Clinically Significant".
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 |
|---|---|---|
| Tacrolimusa single dose of 1 mg capsule per period | Drug | Sequence 1 (TRTR), Sequence 2 (RTRT) |
Primary outcome
Area Under the Concentration (AUC 72)
Time frame: 72 hours
Measurement of whole blood tacrolimus prior to dosing and up to 72 hours post-dose
Maximum Plasma Concentration (Cmax)
Time frame: 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 hours
Measurement of whole blood tacrolimus prior to dosing and up to 144 hours post-dose
3 secondary outcomes
Time at Maximum Plasma Concentration (Tmax)
Time frame: 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 hours
Area Under the Concentration (AUC Inf)
Time frame: Estimated using the last measurable concentration (144 hours)
Area Under the Concentration (AUC 0-t)
Time frame: To the last measurable concentration or last sampling time t, whichever occurs first. (0 to 144 hours post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Plan is to make the deidentified, participant data that underlie the results reported in a publication available to researchers who provide a methodologically sound proposal. In addition, the protocol will be made available online at this registry.
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Screening Protocol
Pain
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.
Artan Markollari, MD principal investigator
BioPharma Services Inc.
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 Tacrolimus in people with Healthy Volunteers, run by Food and Drug Administration (FDA) 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 15 inclusion and 49 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 21 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2023). 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 Concentration (AUC 72) (time frame: 72 hours). 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 21 Sep 2023.