Safety, Tolerability and PK of Single and Multiple Doses of Oxantel Pamoate Tablets

NCT06606860 | Completed Phase 1 DMC

• 1 other identifier: P1773-22A
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of oxantel pamoate tablet after administration of a single and multiple dose in healthy male and female adult volunteers. The main questions aim to answer if oxantel pamoate is safe and well tolerated in healthy volunteers and if is it absorbed by the human body. A single dose and a multiple dose of oxantel pamoate will be compared to placebo to see if there are any different effects.

Conditions

Healthy

Keywords

Soil transmitted helminths; Phase I; Safety; Tolerability; Pharmacokinetics; Trichuriasis; Whipworm; Parasitic Diseases; Neglected Diseases

Outcome Measures

Primary Outcomes (28)

• General safety (number, frequency, severity, seriousness and duration of adverse events)

  Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events

  After first dosage on day 0 to day 14

• Heart rate from baseline

  Change of pulse rate from baseline

  After first dosage on day 0 to day 14

• Blood pressure from baseline

  Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed

  After first dosage on day 0 to day 14

• Temperature from baseline

  Change of axillary temperature from baseline

  After first dosage on day 0 to day 14

• Respiratory rate from baseline

  Change of respiratory rate from baseline

  After first dosage on day 0 to day 14

• Creatinine value from baseline

  Change of creatinine value from baseline

  After first dosage on day 0 to day 14

• Alanine aminotransferase value from baseline

  Change of alanine aminotransferase value from baseline

  After first dosage on day 0 to day 14

• Aspartate aminotransferase value from baseline

  Change of aspartate aminotransferase value from baseline

  After first dosage on day 0 to day 14

• Total bilirubin value from baseline

  Change of total bilirubin value from baseline

  After first dosage on day 0 to day 14

• Sodium value from baseline

  Change of sodium value from baseline

  After first dosage on day 0 to day 14

• Potassium value from baseline

  Change of potassium value from baseline

  After first dosage on day 0 to day 14

• Blood urea nitrogen value from baseline

  Change of blood urea nitrogen value from baseline

  After first dosage on day 0 to day 14

• Haemoglobin value from baseline

  Change of haemoglobin value from baseline

  After first dosage on day 0 to day 14

• Red blood cell count from baseline

  Change of red blood cell count from baseline

  After first dosage on day 0 to day 14

• Mean corpuscular volume from baseline

  Change of mean corpuscular volume from baseline

  After first dosage on day 0 to day 14

• Mean corpuscular haemoglobin value from baseline

  Change of mean corpuscular haemoglobin value from baseline

  After first dosage on day 0 to day 14

• Mean corpuscular haemoglobin concentration from baseline

  Change of mean corpuscular haemoglobin concentration from baseline

  After first dosage on day 0 to day 14

• Platelets value from baseline

  Change of platelets value from baseline

  After first dosage on day 0 to day 14

• White blood cell count from baseline

  Change of white blood cell count from baseline

  After first dosage on day 0 to day 14

• Neutrophils value from baseline

  Change of neutrophils value from baseline

  After first dosage on day 0 to day 14

• Lymphocytes value from baseline

  Change of lymphocytes value from baseline

  After first dosage on day 0 to day 14

• Monocytes value from baseline

  Change of monocytes value from baseline

  After first dosage on day 0 to day 14

• Eosinophils value from baseline

  Change of eosinophils value from baseline

  After first dosage on day 0 to day 14

• Basophils value from baseline

  Change of basophils value from baseline

  After first dosage on day 0 to day 14

• Prothrombin time from baseline

  Change of prothrombin time value from baseline

  After first dosage on day 0 to day 14

• Activated partial thromboplastin time from baseline

  Change of activated partial thromboplastin time value from baseline

  After first dosage on day 0 to day 14

• Protein in urine from baseline

  Change of proteine in urine from baseline

  After first dosage on day 0 to day 14

• Blood in urine from baseline

  Change of blood in urine from baseline

  After first dosage on day 0 to day 14

Secondary Outcomes (7)

• Cmax of oxantel pamoate

  Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose

• Tmax of oxantel pamoate

  Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose

• AUC of oxantel pamoate

  Plasma samples taken pre-dose -0.5 hours, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose

• AUC (0-t) of oxantel pamoate

  Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose

• T1/2 of oxantel pamoate

  Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose

Study Arms (3)

Arm 1

EXPERIMENTAL

Treatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo

Drug: Oxantel Pamoate

Arm 2

EXPERIMENTAL

Treatment with three daily dose of 20 mg/kg oxantel pamoate

Drug: Oxantel Pamoate

Arm 3

PLACEBO COMPARATOR

Treatment with three daily doses of placebo

Drug: Placebo

Interventions

Oxantel Pamoate DRUG

Oxantel Pamoate tablet, 250mg

Arm 1; Arm 2

Placebo DRUG

Placebo tablet

Arm 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants, aged between 18 to 45 years at the time of consent.
• Written informed consent (IC) obtained before any study procedure.
• Ability to read and write and to understand the participant information sheet and the nature of the trial and any hazards from participating in it (following a test with a maximum of two attempts). Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial.
• Women of childbearing potential (WOCBP) must agree to use a highly effective form of contraception from at least 28 days prior to first dosage to 30 days after discharge from the ward.
• Normal body weight range (BMI between 18 and 29.9 kg/ m2).

You may not qualify if:

• Participation in another clinical trial within 3 months prior to the study, or within 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer (time calculated relative to the last dose in the previous clinical trial).
• Regular daily consumption of more than one liter of xanthine-containing beverages (e.g. tea, coffee, cola or chocolate drinks).
• Regular daily consumption of more than 5 cigarettes daily.
• Use of a prescription medicine during the 28 days before the first dose of trial medication or use of an over-the-counter medicine, during the 7 days before the first dose of trial medication.
• Use of dietary supplements or herbal remedies (such as St John\'s Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathway during the 28 days before the first dose of trial medication.
• Therapies which may impact on the interpretation of study results in the opinion of the Investigator.
• Medical, social condition, psychiatric disorder or occupational reasons that, in the judgment of the Investigator, is a contraindication to the protocol, may impair the volunteer's ability to give informed consent or effectively participate in the study, may significantly increase the risk to the volunteer because of participation in the study or may impair interpretation of the study data.
• Blood pressure (BP) and heart rate (HR) in supine position at the screening examination outside the ranges (systolic BP range: 105-136 mm Hg systolic, diastolic BP range: 58-84 mm Hg diastolic; HR range: 56- 96 beats/min).
• Febrile illness within 1 week before the start of study treatment.
• History of relevant diseases of vital organs, of the central nervous system or other organs.
• Known renal or hepatic impairment
• Participants with a history of allergies, non-allergic drug reactions, adverse reaction to any drug, or multiple drug allergies.
• Presence or history of drug or alcohol abuse in the last 10 years.
• Surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally.
• Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer\'s participation in the trial or make it unnecessarily hazardous.

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Ifakara Health Institute: collaborator
• Drugs for Neglected Diseases initiative: collaborator

Study Sites (1)

Ifakara Health Institute

Bagamoyo, Tanzania

Location

MeSH Terms

Conditions

Trichuriasis; Parasitic Diseases; Neglected Diseases

Interventions

oxantel pamoate

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Paris, MD, PhD

  Swiss Tropical & Public Health Institute

  STUDY DIRECTOR

• Jennifer Keiser, PhD

  Swiss Tropical & Public Health Institute

  STUDY CHAIR

• Hussein Mbarak, MD

  Ifakara Health Insitute, Tanzania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: January 27, 2025
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)