PharmacokineticsPhase 1NCT04406415
Oral Nafamostat in Healthy Volunteers (NAF-101)
A Phase 1 study testing Nafamostat Mesilate in people with Pharmacokinetics, run by Ensysce Biosciences at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Nafamostat Mesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 14 May 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, age 18 to 70 years old, able and willing to provide written informed consent to participate in the study;
- Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG);
- Subjects must be willing to remain in confinement at the clinical study unit for 6.5 consecutive days and to return to the unit at Day 14±2 for followup safety assessments;
- Body mass index (BMI) 19-32 kg/m2;
- Normal blood pressure (BP) [systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg] and heart rate (HR) [resting HR 45-90 beats per minute (bpm)] without medication;
- Clinical chemistry profile including electrolytes, alkaline phosphatase (ALK), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), creatinine, and urea must be within the normal range without medication; screening liver enzymes may be up to 1.5x normal range; screening CPK must be within 2x normal range;
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- Urinalysis including urinary creatinine must be within normal limits (trace findings and minor deviations are acceptable per the clinical decision of the Principal Investigator);
- Subjects must be non-smokers or willing to abstain from smoking for the duration of study;
- Subjects must be able to read, understand and follow the study instructions;
- Male subjects and their female sexual partners must agree to use double barrier contraception during the study period and for 2 months afterward, or provide proof of post-menopausal state (minimum 1 year) or surgical sterility.
- Female subjects will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile for at least 3 months, or will agree to use double-barrier contraception from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after Clinic Discharge. Double barrier contraception may include, but is not limited to, non-hormonal intrauterine device with spermicide, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide; having a male sexual partner who agrees to use a male condom with spermicide; or having a sterile sexual partner. Females will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period (Day 14). For all females, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Days -1 to -10).
Who cannot join
- Use of any non-study medication(s) including low dose aspirin for cardiovascular prophylaxis within one week prior and two weeks after receipt of study drug;
- Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five years prior to the screening visit;
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study;
- History of congestive heart failure;
- Use of drugs which are P450 inducers or inhibitors within the past 30 days (e.g. cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin);
- Use of any dietary aids or foods that are known to modulate drug metabolizing enzymes (e.g. St. John's Wort, grapefruit juice) within 14 days of dose administration;
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- History of seizure disorder;
- Serious psychosocial co-morbidities;
- Cognitive or psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit for 6.5 days;
- History of drug or alcohol abuse within one year prior to screening;
- Use of any other investigational drug within 1 month prior to enrollment;
- Use of prescription drugs within 1 month prior to enrollment;
- Use of over the counter medication excluding routine vitamins, but including mega-dose vitamin therapy, within one week of enrollment;
- Donation and/or receipt of any blood or blood products within 3 months prior to enrollment;
- Family history of significant cardiac disease (i.e. sudden death in first degree relative; myocardial infarction prior to 50 years old).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Double-Blind, Placebo-Controlled, Phase 1b Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral Nafamostat Mesylate in Healthy Volunteers Subjects
This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects
Read the detailed description
Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be randomized. Subjects will be stratified to include an equal number of male and female subjects who will receive active drug within each dose cohort, and an equal number of male and female subjects in the combined placebo group. Separate groups of volunteers will be used for each dose cohort. There will be 4 dose cohorts in this study with active drug doses of 10, 50, 100, and 200 mg nafamostat in succeeding cohorts. Each cohort of 5 subjects will enroll 2 male and 2 female to receive active drug and 1 subject (male or female) to receive placebo for a total of 20 subjects. The placebo subject from each cohort will be combined into a placebo cohort that will have 4 subjects to compare to 4 subjects in each of the active dose groups.
- Conditions
- Pharmacokinetics
- Being tested
- Nafamostat Mesilate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat MesilateDrug
Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days
PlaceboDrug
Oral placebo administered three times daily for up to 5 days
| Study group | Role | What they receive |
|---|---|---|
| 10 mg | Experimental | 10 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days Receives: Drug: Nafamostat Mesilate |
| 50 mg | Experimental | 50 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days Receives: Drug: Nafamostat Mesilate |
| 100 mg | Experimental | 100 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days Receives: Drug: Nafamostat Mesilate |
| 200 mg | Experimental | 200 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days Receives: Drug: Nafamostat Mesilate |
| Placebo | Placebo comparator | Placebo administered three times a day (t.i.d., approximately q8h) for up to 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Number of participants with adverse events including out-of-range clinical laboratory measures, vital signs, ECG, and spontaneous adverse event reports throughout the 14 day study period
Measured: 14 Days
Secondary outcomes (4)
Pharmacokinetics (Cmax)
Peak plasma concentrations of nafamostat
Measured: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Pharmacokinetics (Tmax)
Time to peak plasma concentrations of nafamostat
Measured: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Pharmacokinetics (AUC)
Area under the plasma concentration vs. time curve (AUC) for nafamostat
Measured: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Dose Selection
Identify dose of nafamostat to maintain a concentration of 3.5 ng/mL (10 nM) or higher for 4 hours or longer after each dose
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start21 Sep 2020
- Primary completion11 Nov 2020
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Sequential
- Model description
- Double-blind, placebo-controlled, Multiple Ascending Dose (MAD) study with 4 active drug cohorts
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- William K Schmidt, PhD, Study director, Ensysce Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406415
- Sponsor's protocol ID
- NAF-101
- Other IDs
- UG3DA047682-02
- Status last verified
- Sep 2024
- First submitted
- 24 May 2020
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Placebo-Controlled, Phase 1b Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral Nafamostat Mesylate in Healthy Volunteers Subjects
- ClinicalTrials.gov ID
- NCT04406415
- Acronym / sponsor ID
- NAF-101
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects
Detailed description
Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be randomized. Subjects will be stratified to include an equal number of male and female subjects who will receive active drug within each dose cohort, and an equal number of male and female subjects in the combined placebo group. Separate groups of volunteers will be used for each dose cohort. There will be 4 dose cohorts in this study with active drug doses of 10, 50, 100, and 200 mg nafamostat in succeeding cohorts. Each cohort of 5 subjects will enroll 2 male and 2 female to receive active drug and 1 subject (male or female) to receive placebo for a total of 20 subjects. The placebo subject from each cohort will be combined into a placebo cohort that will have 4 subjects to compare to 4 subjects in each of the active dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Double-blind, placebo-controlled, Multiple Ascending Dose (MAD) study with 4 active drug cohorts
| Arm | Type | Receives |
|---|---|---|
| 10 mg | Experimental | Drug: Nafamostat Mesilate10 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 50 mg | Experimental | Drug: Nafamostat Mesilate50 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 100 mg | Experimental | Drug: Nafamostat Mesilate100 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 200 mg | Experimental | Drug: Nafamostat Mesilate200 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered three times a day (t.i.d., approximately q8h) for up to 5 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females, age 18 to 70 years old, able and willing to provide written informed consent to participate in the study;
- Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG);
- Subjects must be willing to remain in confinement at the clinical study unit for 6.5 consecutive days and to return to the unit at Day 14±2 for followup safety assessments;
- Body mass index (BMI) 19-32 kg/m2;
- Normal blood pressure (BP) [systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg] and heart rate (HR) [resting HR 45-90 beats per minute (bpm)] without medication;
Key exclusion criteria (15 listed)
- Use of any non-study medication(s) including low dose aspirin for cardiovascular prophylaxis within one week prior and two weeks after receipt of study drug;
- Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five years prior to the screening visit;
- History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study;
- History of congestive heart failure;
- Use of drugs which are P450 inducers or inhibitors within the past 30 days (e.g. cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin);
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 |
|---|---|---|
| Nafamostat MesilateOral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days | Drug | 10 mg, 100 mg, 200 mg, 50 mg |
| PlaceboOral placebo administered three times daily for up to 5 days | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 14 Days
Number of participants with adverse events including out-of-range clinical laboratory measures, vital signs, ECG, and spontaneous adverse event reports throughout the 14 day study period
4 secondary outcomes
Pharmacokinetics (Cmax)
Time frame: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Pharmacokinetics (Tmax)
Time frame: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Pharmacokinetics (AUC)
Time frame: Pre-dose (0 hr) and at 0.5, 1, 2, 3, 4, 6, and 8 hr after first dose on Day 1 and again after the last dose on Day 5
Dose Selection
Time frame: 5 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Schmidt, PhD study director
Ensysce Biosciences
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 Nafamostat Mesilate in people with Pharmacokinetics, run by Ensysce Biosciences 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 11 inclusion and 15 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 24 Sep 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. Some participants in this study may receive a placebo. 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?
Safety and Tolerability (time frame: 14 Days). 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 24 Sep 2024.