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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
SRI International Clinical Trials Unit
Plymouth, Michigan, United States
Number of Participants with One or More Adverse Events
Time frame: Up to 14 days
Number of Participants with One or More Drug-Related Adverse Events
Time frame: Up to 14 days
Number of Participants with One or More Adverse Events by Maximum Severity
Time frame: Up to 14 days
Number of Participants with One or More Serious Adverse Events
Time frame: Up to 14 days
Observed Maximum Plasma Concentration (Cmax)
Time frame: Up to Day 7
Observed Time to Reach Cmax (Tmax)
Time frame: Up to Day 7
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
Extrapolated to Infinity (AUC0-inf)
Time frame: Up to Day 7
Terminal Half-Life (t 1/2)
Time frame: Up to Day 7
Apparent Volume of Distribution after Oral Administration (V/F)
Time frame: Up to Day 7
Oral Systemic Clearance Rate (CL/F)
Time frame: Up to Day 7
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Cumulative Amount Excreted in Urine
Time frame: Up to Day 7
Cumulative Amount Excreted in Feces
Time frame: Up to Day 7