Healthy Volunteers Clinical Trial
Official title:
A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of NRS 033 in Healthy Volunteers
This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Male or female =18 and =55 years of age at time of consent - Body mass index =18.0 to =35.0 kg/m2 - Medically healthy based on the absence of clinically significant abnormal vital sign - Females must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission; also, females of childbearing potential must agree to use a highly effective means of contraception from Screening until 9 months after receiving the study medication. - Male subjects with female partners of childbearing potential must agree to use a male condom and will be advised of the benefit for a female partner to use a highly effective method of contraception - Agree to stay within National Institute on Alcohol Abuse and Alcoholism (NIAAA) low risk drinking criteria. For women, low-risk drinking is no more than 3 drinks on any single day and no more than 7 drinks per week. For men, it is defined as no more than 4 drinks on any single day and no more than 14 drinks per week. - Agree not to take opioid analgesics. Exclusion Criteria: - Clinically significant medical or psychiatric diagnosis (assessed on history, physical exam, ECG, and/or blood tests; includes significant history of cardiovascular, pulmonary, hepatic, gallbladder, or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease). - Significant neuropsychiatric diagnosis (e.g., major depression, suicidal ideation, multiple sclerosis, dementia) as reported by the subject, or a past history of suicide attempt. - Females who are pregnant, lactating, or likely to become pregnant during the study. - History over last 30 days of consuming alcohol >3 drinks day per day or >7 drinks per week if female; if male >4 drinks per day or >14 drinks per week. - Currently uses tobacco or nicotine containing products, including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum. - Reported history of a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form. - Subject reported history of any use of long-term use of opioids agonists or antagonists; e.g., methadone, oxycodone, hydrocodone, naltrexone, buprenorphine. - Subject reported history of any medications to treat opioid use disorder (MOUD); e.g., methadone, naltrexone, buprenorphine, kratom. - Subject reports anticipated need for opioid analgesia in the next 12 months (e.g., planned surgery). - Subject reports history or presence of allergic or adverse response (including rash or anaphylaxis) to naloxone, naltrexone, nalmefene, morphinan opioid agonists, benzyl alcohol or sesame oil. - Positive urine drug screen (UDS) for barbiturates, benzodiazepines, cocaine, methamphetamine, or opioids. - Positive alcohol breath test. - Received an investigational drug within the last 30 days or 5 half-lives of the drug, whichever is longer, prior to administration of study medication. - Has taken exclusionary prohibited medications within the last 30 days or 5 half-lives of the drug, whichever is longer. - Subjects with a history of syncope, or have a history of symptomatic hypotension or symptomatic hypoglycemia. - Subjects who test positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg), or Hepatitis C virus (HCV) antibody. |
Country | Name | City | State |
---|---|---|---|
United States | Frontage Clinical Research Center | Secaucus | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Nirsum Labs | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Emergent Adverse Events (TEAEs) | Number of Participants with TEAEs | From predose through end of study visit, assessed up to 6 months | |
Primary | Severity of TEAEs | Severity of TEAEs | From predose through end of study visit, assessed up to 6 months | |
Primary | Serious Adverse Events (SAEs) | Number of Participants with SAEs | From predose through end of study visit, assessed up to 6 months | |
Primary | Discontinuation Due to Adverse Events (AEs) | Number of Participants who discontinue the study due to AEs | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: AUC0-last | Area under the plasma concentration-time curve (AUC) from time 0 to last measurable plasma concentration | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: AUC0-infinity | Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC0-last + AUCt-inf | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: AUC0-inf %extrapolation | Percentage of AUC0-inf due to extrapolation from Tlast to infinity | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: Cmax | Maximum observed plasma concentration (Cmax) | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: Tmax | Time of Cmax | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: t1/2 | Terminal half-life (t1/2) | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: Kel (?z) | Apparent terminal rate-constant, calculated using linear regression on the terminal portion of the Log-concentration versus time curve | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: Vz/F | Apparent volume of distribution (Vz/F) | From predose through end of study visit, assessed up to 6 months | |
Primary | Pharmacokinetics: CL/F | Apparent clearance (CL/F) | From predose through end of study visit, assessed up to 6 months |
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