Traumatic Brain Injury (TBI)Phase 1NCT05033444
A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
A Phase 1 study testing PRV-002 in people with Traumatic Brain Injury (TBI), run by Odyssey Group International, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- PRV-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Feb 2022to 13 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adult males and females, 18 to 55 years of age (inclusive) at screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50 kg at screening.
- Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration.
- Have a negative test for cotinine at the screening visit and at check-in on Day -1.
- Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit in the Schedules of
Show all 32Show fewer
- Assessments (SoA), including:
- Physical examination without any clinically significant findings
- Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
- Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
- Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
- No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests
- Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities
- Pulmonary assessments must be within the normal range (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio ≥ 80% of normal values; f forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted)
- Oxygen saturation (SpO2) monitor ≥ 95%.
- Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the timepoints indicated in the Schedules of Assessments (SoA), including:
- Physical examination without any clinically significant findings
- Systolic BP in the range of 90 to 160 mmHg (inclusive) and diastolic BP in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
- Heart rate in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
- Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive)
- No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests
- Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities
- Pulmonary assessments must be within the normal range (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio ≥ 80% of normal values; f forced expiratory flow over the middle one half of the FVC [FEF25-75%] > 75% of predicted)
- Oxygen saturation (SpO2) monitor ≥ 95%.
- Female volunteers must:
- Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause
- Have a follicle-stimulating hormone level >40 IU/L at the screening visit),or
- If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
- Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- -
Who cannot join
- History or presence of significant cardiovascular disease
- History or presence of significant pulmonary disease
- History or presence of significant hepatic disease
- History or presence of significant renal disease
- History or presence of significant haematological disease
- History or presence of significant gastrointestinal disease
Show all 53Show fewer
- History or presence of significant disease
- History or presence of significant endocrine disease
- History or presence of significant immunologic disease
- History or presence of significant dermatologic disease
- History or presence of significant or neurological disease
- No major surgery within the past 3 months determined by the PI to be clinically significant.
- Absence of any acute illness.
- Current infection that requires systemically absorbed antibiotic.
- Current infection that requires systemically absorbed antifungal.
- Current infection that requires systemically absorbed antiparasitic.
- Current infection that requires systemically absorbed antiviral medication.
- Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration.
- History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death).
- Known arrythmia
- Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase
- Liver function test results elevated more than 1.5-fold above the ULN for bilirubin (total)
- Liver function test results elevated more than 1.5-fold above the ULN for bilirubin (conjugated)
- Liver function test results elevated more than 1.5-fold above the ULN for ALP. Volunteers with ALP above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- Liver function test results elevated more than 1.5-fold above the ULN for AST. Volunteers with AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- Liver function test results elevated more than 1.5-fold above the ULN for ALT. Volunteers with ALT above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
- Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2) antibodies at the screening visit.
- Positive test results for active hepatitis B surface antigen (HBsAg) antibodies at the screening visit.
- Positive test results for active hepatitis C virus (HCV) antibodies at the screening visit.
- Presence or having sequelae of known to interfere with the absorption, distribution, metabolism, or excretion of drugs such as gastrointestinal, liver, kidney, or other conditions .
- Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
- History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
- Positive drugs of abuse at the screening visit.
- Positive drugs of abuse at check-in (Day -1).
- Positive alcohol breath test results at the screening visit.
- Positive alcohol breath test results at check-in (Day -1).
- Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days prior to the first study drug administration, - exceptions include use of contraceptives, occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days), ibuprofen (doses of 400 mg up to every 6 hours or 1.6 g per day maximum for no more than 3 consecutive days), topical ointments, and vitamins or dietary supplements.
- Consumption of grapefruit or Seville orange (or products containing grapefruit or Seville orange) within 10 days prior to the first administration of study drug.
- Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
- Known hypersensitivity to any of the study drug ingredients.
- Use of any vaccinations within 14 days prior to the first study drug administration.
- For women of childbearing potential, a positive serum pregnancy test at the screening visit.
- For women of childbearing potential, a positive urine pregnancy test (with confirmatory serum pregnancy test) at check-in (Day -1).
- Females who are breastfeeding or planning to breast feed at any time during the study.
- Donation of blood or plasma within 30 days prior to first study drug administration.
- Loss of whole blood of more than 500 mL within 30 days prior to first study drug administration.
- Receipt of a blood transfusion within 1 year of first study drug administration.
- Participation in another clinical trial of an investigational drug within 60 days of the first study drug administration.
- Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers
Read the detailed description
This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of different dose levels of PRV-002 in Healthy Volunteers. The study will evaluate 3 dose levels of the investigational product, PRV-002, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Cohorts 1 - 3 will receive a single dose of PRV-002 or placebo. Cohorts will receive one dose of PRV-002 or placebo per day for 5 consecutive days.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- PRV-002, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, PRV-002
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-002Drug
Also called Experimental drug
SAD portion: Eligible participants will be randomized to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomized to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.533 mg/kg (based on a 60kg participant) will be investigated.
MAD portion: Eligible participants will be randomized to receive a multiple (one dose per day for 5 consecutive days). Dose escalation will be conducted in a total of 2 cohorts. Within each cohort, 6 participants will be randomized to receive of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.266 mg/kg (based on a 60kg participant) will be investigated.
PlaceboDrug
Also called Placebo control
Placebo used is hydroxypropyl beta cyclodextrin (HPβCD)
| Study group | Role | What they receive |
|---|---|---|
| PRV-002 | Experimental | PRV-002 active formulation Receives: Drug: PRV-002 |
| Placebo comparator | Placebo comparator | Placebo used is hydroxypropyl beta cyclodextrin (HPβCD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)).
AEs/SAEs (or ADEs/SADEs) to be recorded as written descriptions on case report forms
Measured: Baseline pre-intervention (Day -28 to Day -2 and Day -1); during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
Safety endpoint - Change from baseline in physical examination findings (Full)
Full physical exam including general appearance, head, ears, eyes, nose and throat, neck (including thyroid and lymph nodes), respiratory system, cardiovascular system, gastrointestinal system, renal system, neurological condition, musculoskeletal system, skin and any other focused assessments suggested by the presence of specific symptoms and measured by written descriptions.
Measured: Baseline pre-intervention Day -28 to -2.
Safety endpoint - Change from baseline in physical examination findings (symptom directed)
Symptom-directed physical examination (focused assessments suggested by the presence of specific symptoms) will be performed if clinically indicated, as determined by the Investigator. The pre-dose physical examination assessment should be performed on the scheduled day, at any time prior to dosing. All other physical examinations will be performed within ± 1 hour of the nominated timepoint. Measured by written descriptions.
Measured: Baseline pre-intervention Day -1 and and Day 1; Day 2
Safety endpoint - Change from baseline in vital signs (including changes from baseline in SpO2).
SpO2 measured as percent of oxygen (%)
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in vital signs (including changes from baseline in blood pressure).
Blood pressure measured for systolic and diastolic pressure as mm of mercury.
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in vital signs (including changes from baseline in heart rate).
Heart rate measured as beats per minute (BPM)
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in vital signs (including changes from baseline in respiration rate).
Respiration rate measured as breaths per minute
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in vital signs (including changes from baseline in body temperature).
Body temperature measured as degrees Celsius (C)
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Changes from baseline in lung spirometry.
Lung spirometry measured as the ratio of forced expiratory value (FEV1)/ forced vital capacity (FVC) and reported as percentage (%)
Measured: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.25hr, 1hr, 10hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in ECG parameters of heart rate
Heart ratel measured beats per minute (BPM)
Measured: Baseline pre-intervention; during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
Safety endpoint - Change from baseline in ECG parameters of PR interval, QRS interval, and QT interval
PR interval, QRS interval, and QT interval as measured in milliseconds (ms)
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 pre-intervention; Day 1 at 0.5hr, 2hr, 6hr; 12hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in hematocrit values
Hematocrit measured as the percentage of red blood cells in whole blood (%)
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in hemoglobin values
Hemoglobin measured as the amount of hemoglobin in whole blood measured as grams per deciliter (g/dL)
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in Red Blood Cell (RBC) indices
RBC measured as the number of million RBCs per microliter (mcL) of blood
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in Thrombocyte Count (Platelets); White Blood Cells (WBC); Basophils; Eosinophils; Lymphocytes; Monocytes; and Neutrophils.
Platelets measured as the number of cells per microliter (mcL) of blood
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in the blood hormone level of Dehydroepiandrosterone-sulfate (DHEAS)
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (µg/dL) of blood
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of dihydrotestosterone (DHT)
Dihydrotestosterone (DHT) measured as the number of nano moles per liter (nmol/L) of blood
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of luteinizing hormone (LH)
Luteinizing hormone (LH) measured as the number of International units per liter (IU/L)
Measured: Baseline pre-intervention Days -28 to -2
Safety endpoint - Change from baseline in the blood hormone level of dehydroepiandrosterone sulfate (DHEAS)
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (mcg/dL)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of thyroid stimulating hormone (TSH)
Thyroid stimulating hormone (TSH) measured as the number of milli-international units per liter (mIU/L)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - For postmenopausal women only, change from baseline in the blood hormone level of follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH)
Follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH) measured as the number of milli-international units per milliliter (mIU/mL)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT)
Free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT) measured as the number of nanograms per deciliter (ng/dL)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of progesterone
Progesterone measured as the number of nanograms per miiliiliter (ng/mL)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint - Change from baseline in the blood hormone level of estradiol (E2) and free trilodothyronine (FT3)
Estradiol (E2) and free trilodothyronine (FT3) measured as the number of picograms per milliliter (pg/mL)
Measured: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Safety endpoint Change in baseline in clotting factors Partial thromboplastin time (aPTT) and Prothrombin time (PT)
Partial thromboplastin time (aPTT) and Prothrombin time (PT) measured as time to clot in seconds (sec)
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in the clotting factor Fibrinogen
Fibrinogen measured as the number of milligrams per deciliter (mg/dL)
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in the clotting factor International Normalized Ratio (INR)
International Normalized Ratio (INR) measured as the ratio of patient PT/control PT
Measured: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Safety endpoint - Change from baseline in urinalysis parameters bilirubin, blood, glucose, nitrites, protein, and urobilinogen
Bilirubin, blood, glucose, nitrites, protein, and urobilinogen measured as the number of milligrams per deciliter (mg/dL)
Measured: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Safety endpoint - Change from baseline in urinalysis parameter ketones
Ketones measured as the number of millimoles per liter (mmol/L)
Measured: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Safety endpoint - Change from baseline in urinalysis parameter leukocyte esterase
Leukocyte esterase measured as negative or positive; number of WBCs per high power field
Measured: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Safety endpoint - Change from baseline in urinalysis parameter pH
pH measured as pH units
Measured: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Safety endpoint - Change from baseline in urinalysis parameter specific gravity
Specific gravity measured as specific gravity units as a ratio of density of urine/density of water
Measured: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Safety endpoint - Change from baseline in serum chemistry parameters globulin, protein, and albumin
Globulin, protein, and albumin measured as grams per deciliter (g/dL)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in serum chemistry parameter alkaline phosphatase
Alkaline phosphatase measured as International units per liter (IU/L)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in serum chemistry parameters bicarbonate, chloride, sodium, and magnesium
Bicarbonate, chloride, sodium, and magnesium measured as milliequivalents per liter (mEq/L)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in serum calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol
Calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol, triglycerides measured as milligrams per deciliter (mg/dL)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in serum chemistry parameters potassium
Potassium measured as millimoles per liter (mmol/L)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in serum chemistry parameters lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase
Lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase measured as Units per liter (U/L)
Measured: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Safety endpoint - Change from baseline in virology parameters HIV-1/-2; HBsAg; HCV; SARS-COV-2
HIV-1/-2; HBsAg; HCV; SARS-COV-2 test results measured as negative or positive
Measured: Baseline pre-intervention Day -28 to -2
Safety endpoint - Change from baseline in drug screen findings for alcohol
Alcohol test results measured as percentage (%)
Measured: Baseline pre-intervention Day -28 to -2; Day -1
Safety endpoint - Change from baseline in urine drug screen findings for amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants
Urine amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants test results measured as nanograms per milliliter (ng/mL)
Measured: Baseline pre-intervention Day -28 to -2; Day -1
Safety endpoint - Change from baseline for pregnancy test for serum hCG and urine hCG
Serum hCG and Urine hCG levels measured in milli-international units per liter (mIU/L)
Measured: Serum pregnancy test Days -28 to -2 and on Day 5; Urine pregnancy test Day -1
Safety endpoint - Change from baseline for confirmation of postmenopausal status test for FSH
FSH levels measured in milli-international units per liter (mIU/L)
Measured: Baseline pre-intervention on Days -28 to -2
Secondary outcomes (10)
Plasma pharmacokinetics - Cmax
Plasma PRV-002 Cmax measured as microgram per mL (mcg/mL)
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - Tmax
Plasma PRV-002 time to Cmax
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - area under the curve
Plasma PRV-002 Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUC0-t) measured as min*kBq/mL
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - area under the concentration-time curve
Plasma PRV-002 area under the concentration-time curve from 0 to infinity (AUC0-inf) measured as mg*h/L
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - apparent terminal elimination half-life t1/2)
Plasma PRV-002 apparent terminal elimination half-life (t1/2) measured in minutes or hours
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - terminal elimination rate constant (λz)
Plasma PRV-002 terminal elimination rate constant (λz) measured as elimination rate measured as constant K or Ke ((λz))
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics total apparent body clearance
Plasma PRV-002 total apparent body clearance measured as (CL/F)
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - apparent volume of distribution
Plasma PRV-002 apparent volume of distribution measured as (Vz/F)
Measured: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Urine pharmacokinetics - cumulative amount of unchanged drug excreted in urine
Urine PRV-002 cumulative amount of unchanged drug excreted (Ae) in urine measured in micrograms per milliliter (mcg/mL)
Measured: Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.
Urine pharmacokinetics - renal clearance
Urine PRV-002 renal clearance measured as (CLr)
Measured: Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start9 Feb 2022
- Primary completion1 Oct 2022
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odyssey Group International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Philip Ryan, Dr., Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033444
- Sponsor's protocol ID
- PRV-002-AU-01
- Other IDs
- PRV-002-AUU-01
- Status last verified
- Oct 2024
- First submitted
- 12 Aug 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05033444
- Acronym / sponsor ID
- PRV-002-AU-01
- Conditions
- Traumatic Brain Injury (TBI)
- Keywords
- Safety, Tolerability, Pharmacokinetics, PRV-002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odyssey Group International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 2 Sep 2021 (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.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers
Detailed description
This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of different dose levels of PRV-002 in Healthy Volunteers. The study will evaluate 3 dose levels of the investigational product, PRV-002, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Cohorts 1 - 3 will receive a single dose of PRV-002 or placebo. Cohorts will receive one dose of PRV-002 or placebo per day for 5 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study.
| Arm | Type | Receives |
|---|---|---|
| PRV-002 | Experimental | Drug: PRV-002PRV-002 active formulation |
| Placebo comparator | Placebo comparator | Drug: PlaceboPlacebo used is hydroxypropyl beta cyclodextrin (HPβCD) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adult males and females, 18 to 55 years of age (inclusive) at screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50 kg at screening.
- Be non-smokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration.
- Have a negative test for cotinine at the screening visit and at check-in on Day -1.
Key exclusion criteria (53 listed)
- History or presence of significant cardiovascular disease
- History or presence of significant pulmonary disease
- History or presence of significant hepatic disease
- History or presence of significant renal disease
- History or presence of significant haematological disease
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 |
|---|---|---|
| PRV-002Also: Experimental drugSAD portion: Eligible participants will be randomized to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomized to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.533 mg/kg (based on a 60kg participant) will be investigated. MAD portion: Eligible participants will be randomized to receive a multiple (one dose per day for 5 consecutive days). Dose escalation will be conducted in a total of 2 cohorts. Within each cohort, 6 participants will be randomized to receive of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.266 mg/kg (based on a 60kg participant) will be investigated. | Drug | PRV-002 |
| PlaceboAlso: Placebo controlPlacebo used is hydroxypropyl beta cyclodextrin (HPβCD) | Drug | Placebo comparator |
Primary outcome
Safety endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)).
Time frame: Baseline pre-intervention (Day -28 to Day -2 and Day -1); during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
AEs/SAEs (or ADEs/SADEs) to be recorded as written descriptions on case report forms
Safety endpoint - Change from baseline in physical examination findings (Full)
Time frame: Baseline pre-intervention Day -28 to -2.
Full physical exam including general appearance, head, ears, eyes, nose and throat, neck (including thyroid and lymph nodes), respiratory system, cardiovascular system, gastrointestinal system, renal system, neurological condition, musculoskeletal system, skin and any other focused assessments suggested by the presence of specific symptoms and measured by written descriptions.
Safety endpoint - Change from baseline in physical examination findings (symptom directed)
Time frame: Baseline pre-intervention Day -1 and and Day 1; Day 2
Symptom-directed physical examination (focused assessments suggested by the presence of specific symptoms) will be performed if clinically indicated, as determined by the Investigator. The pre-dose physical examination assessment should be performed on the scheduled day, at any time prior to dosing. All other physical examinations will be performed within ± 1 hour of the nominated timepoint. Measured by written descriptions.
Safety endpoint - Change from baseline in vital signs (including changes from baseline in SpO2).
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
SpO2 measured as percent of oxygen (%)
Safety endpoint - Change from baseline in vital signs (including changes from baseline in blood pressure).
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Blood pressure measured for systolic and diastolic pressure as mm of mercury.
Safety endpoint - Change from baseline in vital signs (including changes from baseline in heart rate).
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Heart rate measured as beats per minute (BPM)
Safety endpoint - Change from baseline in vital signs (including changes from baseline in respiration rate).
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Respiration rate measured as breaths per minute
Safety endpoint - Change from baseline in vital signs (including changes from baseline in body temperature).
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.5hr, 1hr, 2hr, 6hr; Day 2 at 24 hr post intervention; Day 5
Body temperature measured as degrees Celsius (C)
Safety endpoint - Changes from baseline in lung spirometry.
Time frame: Baseline pre-intervention between Day -28 to -2; Day 1 pre-intervention; Day 1 at 0.25hr, 1hr, 10hr; Day 2 at 24 hr post intervention; Day 5
Lung spirometry measured as the ratio of forced expiratory value (FEV1)/ forced vital capacity (FVC) and reported as percentage (%)
Safety endpoint - Change from baseline in ECG parameters of heart rate
Time frame: Baseline pre-intervention; during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.
Heart ratel measured beats per minute (BPM)
Safety endpoint - Change from baseline in ECG parameters of PR interval, QRS interval, and QT interval
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 pre-intervention; Day 1 at 0.5hr, 2hr, 6hr; 12hr; Day 2 at 24 hr post intervention; Day 5
PR interval, QRS interval, and QT interval as measured in milliseconds (ms)
Safety endpoint - Change from baseline in hematocrit values
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Hematocrit measured as the percentage of red blood cells in whole blood (%)
Safety endpoint - Change from baseline in hemoglobin values
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Hemoglobin measured as the amount of hemoglobin in whole blood measured as grams per deciliter (g/dL)
Safety endpoint - Change from baseline in Red Blood Cell (RBC) indices
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
RBC measured as the number of million RBCs per microliter (mcL) of blood
Safety endpoint - Change from baseline in Thrombocyte Count (Platelets); White Blood Cells (WBC); Basophils; Eosinophils; Lymphocytes; Monocytes; and Neutrophils.
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Platelets measured as the number of cells per microliter (mcL) of blood
Safety endpoint - Change from baseline in the blood hormone level of Dehydroepiandrosterone-sulfate (DHEAS)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (µg/dL) of blood
Safety endpoint - Change from baseline in the blood hormone level of dihydrotestosterone (DHT)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Dihydrotestosterone (DHT) measured as the number of nano moles per liter (nmol/L) of blood
Safety endpoint - Change from baseline in the blood hormone level of luteinizing hormone (LH)
Time frame: Baseline pre-intervention Days -28 to -2
Luteinizing hormone (LH) measured as the number of International units per liter (IU/L)
Safety endpoint - Change from baseline in the blood hormone level of dehydroepiandrosterone sulfate (DHEAS)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Dehydroepiandrosterone sulfate (DHEAS) measured as the number of micrograms per deciliter (mcg/dL)
Safety endpoint - Change from baseline in the blood hormone level of thyroid stimulating hormone (TSH)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Thyroid stimulating hormone (TSH) measured as the number of milli-international units per liter (mIU/L)
Safety endpoint - For postmenopausal women only, change from baseline in the blood hormone level of follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hGH) measured as the number of milli-international units per milliliter (mIU/mL)
Safety endpoint - Change from baseline in the blood hormone level of free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Free thyroxine (FT4), testosterone, and dihydrotestosterone (DHT) measured as the number of nanograms per deciliter (ng/dL)
Safety endpoint - Change from baseline in the blood hormone level of progesterone
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Progesterone measured as the number of nanograms per miiliiliter (ng/mL)
Safety endpoint - Change from baseline in the blood hormone level of estradiol (E2) and free trilodothyronine (FT3)
Time frame: Baseline pre-intervention Day -1; Day 1 at 6hr; Day 2 at 24 hr; Day 5
Estradiol (E2) and free trilodothyronine (FT3) measured as the number of picograms per milliliter (pg/mL)
Safety endpoint Change in baseline in clotting factors Partial thromboplastin time (aPTT) and Prothrombin time (PT)
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Partial thromboplastin time (aPTT) and Prothrombin time (PT) measured as time to clot in seconds (sec)
Safety endpoint - Change from baseline in the clotting factor Fibrinogen
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
Fibrinogen measured as the number of milligrams per deciliter (mg/dL)
Safety endpoint - Change from baseline in the clotting factor International Normalized Ratio (INR)
Time frame: Baseline pre-intervention between Day -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24 hr post intervention; Day 5
International Normalized Ratio (INR) measured as the ratio of patient PT/control PT
Safety endpoint - Change from baseline in urinalysis parameters bilirubin, blood, glucose, nitrites, protein, and urobilinogen
Time frame: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Bilirubin, blood, glucose, nitrites, protein, and urobilinogen measured as the number of milligrams per deciliter (mg/dL)
Safety endpoint - Change from baseline in urinalysis parameter ketones
Time frame: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Ketones measured as the number of millimoles per liter (mmol/L)
Safety endpoint - Change from baseline in urinalysis parameter leukocyte esterase
Time frame: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Leukocyte esterase measured as negative or positive; number of WBCs per high power field
Safety endpoint - Change from baseline in urinalysis parameter pH
Time frame: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
pH measured as pH units
Safety endpoint - Change from baseline in urinalysis parameter specific gravity
Time frame: Post dose Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24hr
Specific gravity measured as specific gravity units as a ratio of density of urine/density of water
Safety endpoint - Change from baseline in serum chemistry parameters globulin, protein, and albumin
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Globulin, protein, and albumin measured as grams per deciliter (g/dL)
Safety endpoint - Change from baseline in serum chemistry parameter alkaline phosphatase
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Alkaline phosphatase measured as International units per liter (IU/L)
Safety endpoint - Change from baseline in serum chemistry parameters bicarbonate, chloride, sodium, and magnesium
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Bicarbonate, chloride, sodium, and magnesium measured as milliequivalents per liter (mEq/L)
Safety endpoint - Change from baseline in serum calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Calcium, glucose, phosphate, creatinine, urea, uric acid, bilirubin (conjugated and unconjugated), high density lipoproteins, low density lipoproteins, total bilirubin, total cholesterol, triglycerides measured as milligrams per deciliter (mg/dL)
Safety endpoint - Change from baseline in serum chemistry parameters potassium
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Potassium measured as millimoles per liter (mmol/L)
Safety endpoint - Change from baseline in serum chemistry parameters lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase
Time frame: Baseline pre-intervention Days -28 to -2; Day -1; Day 1 at 6hr; Day 2 at 24hr; Day 5.
Lipase, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyl transferase, alanine aminotransferase, and amylase measured as Units per liter (U/L)
Safety endpoint - Change from baseline in virology parameters HIV-1/-2; HBsAg; HCV; SARS-COV-2
Time frame: Baseline pre-intervention Day -28 to -2
HIV-1/-2; HBsAg; HCV; SARS-COV-2 test results measured as negative or positive
Safety endpoint - Change from baseline in drug screen findings for alcohol
Time frame: Baseline pre-intervention Day -28 to -2; Day -1
Alcohol test results measured as percentage (%)
Safety endpoint - Change from baseline in urine drug screen findings for amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants
Time frame: Baseline pre-intervention Day -28 to -2; Day -1
Urine amphetamines, barbiturates, benzodiazepines, cocaine, cotinine, methamphetamines, opiates, phencyclidine, THC, and tricyclic antidepressants test results measured as nanograms per milliliter (ng/mL)
Safety endpoint - Change from baseline for pregnancy test for serum hCG and urine hCG
Time frame: Serum pregnancy test Days -28 to -2 and on Day 5; Urine pregnancy test Day -1
Serum hCG and Urine hCG levels measured in milli-international units per liter (mIU/L)
Safety endpoint - Change from baseline for confirmation of postmenopausal status test for FSH
Time frame: Baseline pre-intervention on Days -28 to -2
FSH levels measured in milli-international units per liter (mIU/L)
10 secondary outcomes
Plasma pharmacokinetics - Cmax
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - Tmax
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - area under the curve
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - area under the concentration-time curve
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - apparent terminal elimination half-life t1/2)
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - terminal elimination rate constant (λz)
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics total apparent body clearance
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Plasma pharmacokinetics - apparent volume of distribution
Time frame: Samples collected on Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2. 3, 4, 6, 10, 12hrs; Day 2 at 24 hr; Day 5.
Urine pharmacokinetics - cumulative amount of unchanged drug excreted in urine
Time frame: Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.
Urine pharmacokinetics - renal clearance
Time frame: Baseline pre-intervention on Day -1; Day 1 at 0 to 6hr, 6 to 12hr, and 12 to 24 hr.
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 4 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury (TBI)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
Philip Ryan, Dr. principal investigator
Nucleus Network
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 PRV-002 in people with Traumatic Brain Injury (TBI), run by Odyssey Group International, Inc. at 1 site in Australia.
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 32 inclusion and 53 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 4 Nov 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 Australia. 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 endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)). (time frame: Baseline pre-intervention (Day -28 to Day -2 and Day -1); during intervention and immediately afterwards (Day 1); Day 2; and through Day 5.). The study lists 43 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 4 Nov 2024.