Healthy SubjectPhase 1NCT05358756
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
A Phase 1 study testing SACT-1 and EDURANT 25Mg Tablet in people with Healthy Subject, run by Aptorum International Limited at 1 site in United States.
Trial summary
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- SACT-1 and EDURANT 25Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2021to 14 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers ≥ 18 years of age.
- Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective contraceptive methods throughout the course of the study and for 30 days after the last dose of study drug. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea and a serum FSH concentration ≥ 40 IU/L), or at least 6 weeks following surgical menopause (bilateral oophorectomy).
- Females of childbearing potential and male subjects with female partners of childbearing potential must agree to use at least 1 of the following acceptable birth control methods during the study and for at least 30 days after the last dose:
- IUD in place for at least 3 months.
- Abstinence (not having heterosexual vaginal intercourse).
- Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion and for 30 days after the last dose of study drug.
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- Stable hormonal contraceptive for at least 3 months prior to study and through study completion (an additional barrier method must be used during the study) and for 30 days after the last dose of study drug. Oral contraceptive use is not permitted in this study.
- Monogamous relationship with a vasectomized partner.
- Able to understand and provide signed informed consent.
- Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
- Females of childbearing potential must have a negative serum hCG pregnancy test at screening.
- BMI ≥ 19.0 and < 32.0.
- Willing and able to consume the entire assigned meals, which include meat, dairy and carbohydrate components, within the designated time frames.
- Subjects must have normal hepatic function at the Screening Visit, defined as the following:
- Alanine aminotransferase <1.5 × upper limit of normal (ULN); or
- Aspartate aminotransferase < 1.5 × ULN; and
- Total bilirubin level <1.5 × ULN.
- Subjects must have creatinine within normal limits or, for subjects with levels above the laboratory normal value, the calculated corrected creatinine clearance must be ≥60 mL/min/1.73 m2 using the Cockcroft-Gault formula corrected for the body surface area.
Who cannot join
- Known or suspected pregnancy, planned pregnancy, or lactation.
- History of allergic reaction to rilpivirine or other related drugs.
- Clinically significant illness or surgery within 4 weeks prior to dosing (including flu, flulike symptoms, diarrhea, vomiting).
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- Any clinically significant abnormal laboratory test results found during medical screening.
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- A history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study.
- Clinically significant history or presence of any gastrointestinal pathology (eg, chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (eg, diarrhea vomiting), liver or kidney disease, gastric bypass, gastric stapling, use of Lapband, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant by the Investigator.
- Use of prescription medication within 14 days prior to administration of study drug or OTC medicines (including natural food supplements and vitamins) within 14 days prior to administration of study drug.
- Use of any tobacco- or nicotine- containing product in the 3 months preceding the Period 1 dose administration.
- Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- Recent history of (within the past 12 months), or strong potential for, alcoholic substance abuse. Alcohol abused will be defined as > 14 drinks per week (1 drink = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).
- Exposure to any investigational agent within 30 days prior to study entry.
- Subjects who donated (standard donation amount or more) blood or blood products (with the exception of plasma as noted below) within 56 days prior to the study.
- Subjects who have made a plasma donation with 7 days prior to the study.
- Subject who has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
- Positive SARS-CoV-2 test.
- Subject currently taking oral contraceptives (for contraceptive and/or other medical purposes).
- Unable or unwilling, due to allergy, food intolerance, dietary preference, or dietary restriction, to eat the assigned meals.
- Known diagnosis of a mood disorder.
- Subject has received any vaccine within 14 days prior to administration of study drug, or has any vaccination scheduled during the study period (from screening up until scheduled end-of-study-visit).
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Fargo, North Dakota, 58104
About this study
Official title: A Phase 1, Open-label, Randomized, 3-period, 3-sequence, Single-dose Crossover Bioavailability and Food Effect Study of SACT-1 (Rilpivirine Suspension) and Edurant® Tablets in Healthy Adult Volunteers
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
Read the detailed description
The subject population included 16 healthy subjects (11 male, 5 female) who received each of the following treatments in a randomized sequence:
Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
On the morning of Day 1 of each study period, subjects received a dose of either Treatment A, Treatment B, or Treatment C after a supervised overnight fast of at least 10 hours (fasted) or after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed). In the fed arms of the study, subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing.
Blood samples were collected at pre-dose and at specified time points over 240 hours after dosing in each study period. Subjects were confined at the clinical facility from check-in until after the 48-hour blood sample collection and returned to the clinic for the 96-, 168- and 240-hour blood samples in each study period. The interval between doses was 14 days.
The plasma concentrations of rilpivirine were measured by the bioanalytical facility using a fully validated analytical procedure. Statistical analysis using an average bioavailability approach was performed to estimate the bioavailability of the test formulation relative to the reference product under fed conditions. The bioavailability of the test product under fasted and fed conditions was also compared.
For evaluation of the safety endpoint, the following assessments were performed throughout the study: collection of medication history and Adverse Events (AEs), laboratory tests (including pregnancy testing), vital signs, physical examination, and 12-lead electrocardiograms (ECGs). PK-ECG correlation analysis was performed to evaluate the correlation between drug concentrations and time-matched baseline corrected values for QTc interval, ΔQTcF and ΔQTcB.
- Conditions
- Healthy Subject
- Being tested
- SACT-1, EDURANT 25Mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SACT-1Drug
Single administartion of 150mg SACT-1
EDURANT 25Mg TabletDrug
Single administartion of six EDURANT 25mg tablets (Total 150mg)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A :Fasted | Experimental | A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours. Receives: Drug: SACT-1 |
| Treatment B: Fed | Experimental | A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. Receives: Drug: SACT-1 |
| Treatment C: Fed | Active comparator | Adminstartion of Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. Receives: Drug: EDURANT 25Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability of SACT-1 and Edurant Tablet
Compare the relative bioavailability of 150 mg SACT-1 (oral suspension) under fasted and fed conditions to 150 mg Edurant® (6 × 25 mg rilpivirine, oral tablets) under fed conditions.
Measured: Up to 240 hours after dosing in each study period
Secondary outcomes (2)
Number of subjects with Adverse Events
Adverse event or AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. An AE can arise from any use of the drug (eg, off-label use, use in combination with another drug) and from any route of administration, formulation, or dose, including an overdose.
Measured: Up to 14 days after the final dose of the study drug.
The effect of food (fasted or fed condition) on potential QT prolongation from administration of a single dose of 150 mg rilpivirine in healthy adult subjects.
Pharmacokinetic - Electrocardiogram (PK-ECG) correlation analysis was performed to evaluate the correlation between drug concentrations and time-matched baseline corrected values for corrected QT (QTc) interval, ΔQTcF and ΔQTcB.
Measured: Up to 24 hours after dosing in each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start9 Oct 2021
- Primary completion20 Nov 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Crossover
- Model description
- Each of the following treatments were given to subjects in a randomized sequence: Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptorum International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lee, PhD, Principal investigator, Aptorum International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358756
- Sponsor's protocol ID
- 12190001
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, 3-period, 3-sequence, Single-dose Crossover Bioavailability and Food Effect Study of SACT-1 (Rilpivirine Suspension) and Edurant® Tablets in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05358756
- Acronym / sponsor ID
- 12190001
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aptorum International LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 3 May 2022 (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 was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
Detailed description
The subject population included 16 healthy subjects (11 male, 5 female) who received each of the following treatments in a randomized sequence:
Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
On the morning of Day 1 of each study period, subjects received a dose of either Treatment A, Treatment B, or Treatment C after a supervised overnight fast of at least 10 hours (fasted) or after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed). In the fed arms of the study, subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing.
Blood samples were collected at pre-dose and at specified time points over 240 hours after dosing in each study period. Subjects were confined at the clinical facility from check-in until after the 48-hour blood sample collection and returned to the clinic for the 96-, 168- and 240-hour blood samples in each study period. The interval between doses was 14 days.
The plasma concentrations of rilpivirine were measured by the bioanalytical facility using a fully validated analytical procedure. Statistical analysis using an average bioavailability approach was performed to estimate the bioavailability of the test formulation relative to the reference product under fed conditions. The bioavailability of the test product under fasted and fed conditions was also compared.
For evaluation of the safety endpoint, the following assessments were performed throughout the study: collection of medication history and Adverse Events (AEs), laboratory tests (including pregnancy testing), vital signs, physical examination, and 12-lead electrocardiograms (ECGs). PK-ECG correlation analysis was performed to evaluate the correlation between drug concentrations and time-matched baseline corrected values for QTc interval, ΔQTcF and ΔQTcB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each of the following treatments were given to subjects in a randomized sequence: Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine [equivalent to 33.0 mg of rilpivirine hydrochloride] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
| Arm | Type | Receives |
|---|---|---|
| Treatment A :Fasted | Experimental | Drug: SACT-1A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours. |
| Treatment B: Fed | Experimental | Drug: SACT-1A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. |
| Treatment C: Fed | Active comparator | Drug: EDURANT 25Mg TabletAdminstartion of Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy male or female volunteers ≥ 18 years of age.
- Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective contraceptive methods throughout the course of the study and for 30 days after the last dose of study drug. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea and a serum FSH concentration ≥ 40 IU/L), or at least 6 weeks following surgical menopause (bilateral oophorectomy).
- Females of childbearing potential and male subjects with female partners of childbearing potential must agree to use at least 1 of the following acceptable birth control methods during the study and for at least 30 days after the last dose:
- Able to understand and provide signed informed consent.
- Normally active and otherwise judged to be in good health on the basis of medical history and physical examination.
Key exclusion criteria (22 listed)
- Known or suspected pregnancy, planned pregnancy, or lactation.
- History of allergic reaction to rilpivirine or other related drugs.
- Clinically significant illness or surgery within 4 weeks prior to dosing (including flu, flulike symptoms, diarrhea, vomiting).
- Positive test for hepatitis B, hepatitis C, or HIV at screening
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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 |
|---|---|---|
| SACT-1Single administartion of 150mg SACT-1 | Drug | Treatment A :Fasted, Treatment B: Fed |
| EDURANT 25Mg TabletSingle administartion of six EDURANT 25mg tablets (Total 150mg) | Drug | Treatment C: Fed |
Primary outcome
Relative Bioavailability of SACT-1 and Edurant Tablet
Time frame: Up to 240 hours after dosing in each study period
Compare the relative bioavailability of 150 mg SACT-1 (oral suspension) under fasted and fed conditions to 150 mg Edurant® (6 × 25 mg rilpivirine, oral tablets) under fed conditions.
2 secondary outcomes
Number of subjects with Adverse Events
Time frame: Up to 14 days after the final dose of the study drug.
The effect of food (fasted or fed condition) on potential QT prolongation from administration of a single dose of 150 mg rilpivirine in healthy adult subjects.
Time frame: Up to 24 hours after dosing in each study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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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.
Thomas Lee, PhD principal investigator
Aptorum International Limited
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 SACT-1 and EDURANT 25Mg Tablet in people with Healthy Subject, run by Aptorum International Limited 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 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. 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?
Relative Bioavailability of SACT-1 and Edurant Tablet (time frame: Up to 240 hours after dosing in each study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.