A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat

• Status: Completed
• Trial end date: 2016-08-24
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SIGA Technologies
• Collaborator: Biomedical Advanced Research and Development Authority

Criteria

Inclusion Criteria:

• 18 to 80 years old, inclusive

• Available for clinical follow-up for the duration of the study

• Able and willing to give informed consent

• In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for the last 2 years

• Able to comply with dietary requirements throughout the study drug dosing period

• Adequate venous access for those individuals participating in PK testing

• PE and laboratory results without clinically significant findings within the 14 days before receipt of study drug

• Agree not to drink alcohol from the beginning of the Screening Period through the completion of the Day 28 Follow up Visit

• Agree not to use any nicotine products, including electronic vapor cigarettes, nicotine patches or nicotine gum for at least 30 days before the Day 1 Visit and through completion of the Day 15 Dosing complete Visit

• Agree not to consume caffeine during all study visits, including overnight stays if participating in PK subset

• Agree not to receive any immunizations/vaccinations

• Agree not to take herbal products

• Able and willing to refrain from taking any prescriptions and nonprescription medications with exceptions

• For women of childbearing potential, negative serum and urine pregnancy testing

• If male, agree not to donate sperm

• Meet 1 of the following criteria: The subject or their partner has undergone surgical sterilization; the subject is postmenopausal; the subject agrees to be abstinent; the subject agrees to consistently use a method of approved birth control.

Exclusion Criteria:

• Pregnant or breast-feeding or planning pregnancy

• Have a history of any clinically significant conditions

• Have any limitation of activity related to cardiac disease

• Have a bleeding disorder diagnosed by a doctor, or a history of significant bruising or bleeding with intramuscular injections or blood draws

• Currently using certain medications

• Have a malignancy that is active or a treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study

• Have a history of seizure

• Have a clinically significant blood dyscrasia

• Have a history of drug allergy that contraindicates participation in the trial

• Have a medical, psychiatric, or social condition or any occupational reason, or other responsibility that in the judgment of the investigator would render the subject unable to comply with the protocol

• Have an inability to swallow medication

• Have a clinically significant abnormal ECG

• Have participated in a clinical trials within 30 days of study entry or planning to participate in any experimental treatment study during the study period

• Have a history or current drug or alcohol abuse

• Have received immunizations/vaccines

• Have a current clinically significant acute bacterial, fungal, or mycobacterial infection requiring administration of systemic antibiotics

• Have known chronic bacterial, mycobacterial, fungal, parasitic, or protozoal infection with the exception of clinically significant dermal infections

• Have known hepatitis B or C infection, or positive test result

• Have known HIV infection or AIDS or a positive test for HIV

• Have a current clinically significant viral infection

• Have known clinically significant chronic viral infection

• have received treatment with greater than 20 mg prednisone or equivalent dose or any immunosuppressant or immunomodulary medication

• Have abnormal laboratory testing during screening

• Have a greater than or equal than 20% risk of suffering a major cardiovascular event

• Have been previously enrolled in this or any clinical trial involving tecovirimat