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Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05628961
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
SRI International

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Toxicity;Chemical Drug: HOPO 14-1 Phase 1

Detailed Description:
The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: 100 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 2: 200 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 3: 500 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 4: 1200 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 5: 2500 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 6: 5000 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
Experimental: Cohort 7: 7500 mg
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
 Drug: HOPO 14-1
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Adverse Events [ Time Frame: Up to 14 days ]
  2. Number of Participants with One or More Drug-Related Adverse Events [ Time Frame: Up to 14 days ]
  3. Number of Participants with One or More Adverse Events by Maximum Severity [ Time Frame: Up to 14 days ]
  4. Number of Participants with One or More Serious Adverse Events [ Time Frame: Up to 14 days ]

Secondary Outcome Measures :
  1. Observed Maximum Plasma Concentration (Cmax) [ Time Frame: Up to Day 7 ]
  2. Observed Time to Reach Cmax (Tmax) [ Time Frame: Up to Day 7 ]
  3. Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast) [ Time Frame: Up to Day 7 ]
  4. Extrapolated to Infinity (AUC0-inf) [ Time Frame: Up to Day 7 ]
  5. Terminal Half-Life (t 1/2) [ Time Frame: Up to Day 7 ]
  6. Apparent Volume of Distribution after Oral Administration (V/F) [ Time Frame: Up to Day 7 ]
  7. Oral Systemic Clearance Rate (CL/F) [ Time Frame: Up to Day 7 ]
  8. Cumulative Amount Excreted in Urine [ Time Frame: Up to Day 7 ]
  9. Cumulative Amount Excreted in Feces [ Time Frame: Up to Day 7 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05628961


Contacts
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Contact: Medical Director 734-527-4200 clinical-trials@sri.com
Contact: Director Clinical Operations 734-527-4200 clinical-trials@sri.com

Locations
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United States, Michigan
SRI Biosciences Clinical Trials Unit Recruiting
Plymouth, Michigan, United States, 48170
Contact: Clinical Site Manager    734-527-4200    clinical-trials@sri.com   
Sponsors and Collaborators
SRI International
Investigators
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Principal Investigator: Principal Investigator SRI International
More Information
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Responsible Party: SRI International
ClinicalTrials.gov Identifier: NCT05628961    
Other Study ID Numbers: SRI-HOPO-01
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SRI International:
Internal Radionuclide Contamination