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Phase 1 Completed N=70 Randomized Double-blind Treatment

Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole

Neurocysticercosis
Source: ClinicalTrials.gov NCT02234570 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose. — 0; 0; 1; 0 Participants

Summary

The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The description of agent used is single oral dose of an aqueous suspension of oxfendazole, a benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two week safety data for the preceding group have been reviewed. If a clinically significant AE is observed, and if this event is drug-related the safety monitoring committee will be convened to determine whether the study should continue.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.
0; 0; 1; 0; 0; 1
SECONDARY
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole
11682.4; 13117.7; 30803.1; 73928.9; 99542.6; 78344.0
SECONDARY
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma
943.9; 1155.9; 2436.9; 4781.3; 6254.8; 5301.3
SECONDARY
Plasma Concentrations of Oxfendazole Fenbendazole
0; 0; 0.3; 0.3; 1.0; 1.4
SECONDARY
Plasma Concentrations of Oxfendazole Sulfone
28.5; 31.1; 73.0; 100.5; 111.6; 161.5
SECONDARY
Terminal Elimination Half-life (t1/2) of Oxfendazole
9.1; 8.5; 10.3; 9.6; 10.0; 9.8
SECONDARY
Time of Maximum Observed Concentration (Tmax) of Oxfendazole
2.0; 2.0; 2.0; 2.0; 2.0; 2.0
SECONDARY
Urine Concentrations of Oxfendazole Fenbendazole
0; 0; 0; 0; 0; 0
SECONDARY
Urine Concentrations of Oxfendazole Sulfone
9.1; 4.1; 19.9; 45.6; 46.4; 68.0

Eligibility Criteria

Inclusion Criteria

  • Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels. 2. In good health, as judged by the investigator and determined by vital signs* Temperature 50 bpm, systolic blood pressure 89 mmHg, diastolic blood pressure /= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and /= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator. 3. Acceptable screening laboratories* *Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST /=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled). 4. Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study. 5. Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD does not exclude participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an experimental agent* within 1 month before administration of study drug or expect to receive an experimental agent during the 15-day study period. *Vaccine, drug, biologic, device, blood product, or medication. 10. Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study. 11. A history of alcohol consumption* or any illicit drug use†, or history of substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to enrollment through day 15. *Greater than 7 alcoholic drinks per week. †Other than occasional marijuana use (less than once per week for the past 60 days is acceptable). #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in the past 60 days.* *A history of occasional tobacco use (less than 1 pack per week on average) is acceptable. Individuals will be counseled to abstain from use of tobacco and marijuana from screening through day 15.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02234570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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