Toxicity;Chemical Clinical Trial
Official title:
An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants
The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.
| Status | Recruiting |
| Enrollment | 42 |
| Est. completion date | April 2024 |
| Est. primary completion date | April 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements - Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential. - In good general health based on medical history, physical examination (PE), and screening evaluations. - Negative urine or blood screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen). - Body weight = 50 kilogram (kg) and = 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be = 40 kg/m^2. Exclusion Criteria: - Inability or unwillingness of a participant to give written informed consent or comply with study protocol. - Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher. - Any clinically significant electrocardiogram (ECG) abnormality - Pregnant or breastfeeding - Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol. - Received an organ transplant (solid or bone marrow). - Received a blood transfusion within 3 months of dosing. - Difficulty swallowing tablets or capsules. - Febrile illness or significant infection within 7 days of dosing. - Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing. - Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). - Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing. - Chelation therapy (e.g., ethylenediaminetetraacetic acid [EDTA], diethylenetriamine pentaacetate [DTPA]) in the past year. - Use of laxatives, antibiotics, and/or antacids within 7 days of dosing. - Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer. - Received a vaccination within 30 days of dosing. - Potential allergic reaction to product (oleic acid or HOPO 14-1 product). - Past or current medical problems or findings from physical examination (PE) or laboratory testing |
| Country | Name | City | State |
|---|---|---|---|
| United States | SRI Biosciences Clinical Trials Unit | Plymouth | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| SRI International |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with One or More Adverse Events | Up to 14 days | ||
| Primary | Number of Participants with One or More Drug-Related Adverse Events | Up to 14 days | ||
| Primary | Number of Participants with One or More Adverse Events by Maximum Severity | Up to 14 days | ||
| Primary | Number of Participants with One or More Serious Adverse Events | Up to 14 days | ||
| Secondary | Observed Maximum Plasma Concentration (Cmax) | Up to Day 7 | ||
| Secondary | Observed Time to Reach Cmax (Tmax) | Up to Day 7 | ||
| Secondary | Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast) | Up to Day 7 | ||
| Secondary | Extrapolated to Infinity (AUC0-inf) | Up to Day 7 | ||
| Secondary | Terminal Half-Life (t 1/2) | Up to Day 7 | ||
| Secondary | Apparent Volume of Distribution after Oral Administration (V/F) | Up to Day 7 | ||
| Secondary | Oral Systemic Clearance Rate (CL/F) | Up to Day 7 | ||
| Secondary | Cumulative Amount Excreted in Urine | Up to Day 7 | ||
| Secondary | Cumulative Amount Excreted in Feces | Up to Day 7 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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