Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

Completed · Phase 3 · Has a placebo group

Conditions studied: Smallpox

In brief

This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.

Key facts

Study ID: NCT04971109
Run by: SIGA Technologies
People needed: 467
Starts: 2022-03-29
Expected to finish: 2023-05-12
Last updated by the study team: 2024-12-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subject is male or female between 18 and 80 years of age, inclusive.
Subject is available for clinical follow-up for the duration of the study.
Women of childbearing potential have a negative beta human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative pregnancy test on Day 1 or Day -1 (PK subset) before receipt of study drug, and meet one of the following criteria:
Subject or their partner has undergone surgical sterilization.
Subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle stimulating hormone level >40 IU/mL.
Subject agrees to be abstinent (ie, heterosexually inactive) for the duration of the study.
Subject agrees to consistently use 1 of the following methods of contraception from the beginning of screening (which they had been consistently using for at least 30 days before the first dose of study drug) through 30 days after the last dose of study drug:
i. Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after the last dose of study drug. Male and female condoms should not be used together, as this can reduce their effectiveness.
ii. Diaphragm or cervical cap with spermicide iii. Intrauterine device with spermicide iv. Oral contraceptives or other hormonal methods NOTE: Another nonhormonal method of contraception must be used in conjunction with oral contraceptives.
v. Male sexual partner who had undergone a vasectomy at least 3 months before screening
Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
Subject agrees not to use nicotine products, including electronic vapor cigarettes, nicotine patches, or nicotine gum, for at least 30 days before the Day 1 randomization visit through completion of the Day 29 dosing complete/early termination (ET) visit.
Subject agrees to comply with the study dietary requirements throughout the study drug dosing period.
Subject agrees not to consume caffeine- or xanthine-containing products during all study visits, including overnight stays (PK subset); sodas, coffee, and tea designated as caffeine free or noncaffeinated may be consumed on study days; caffeine may be consumed while at home and between study visits.
Subject agrees to comply with all protocol requirements.
Subject has adequate venous access if participating in the PK subset.
Subject is able and willing to provide written informed consent.

You may not qualify if…

Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
Subject has a history of any clinically significant conditions including:
Asthma treated with oral systemic steroids within the past 6 months
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or >90 mmHg diastolic)
Thyroidectomy or thyroid disease that required medication within the past 12 months
Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
History of head trauma resulting in a diagnosis of traumatic brain injury other than concussion
Frequent episodes of headache
Subject has received any vaccination within 28 days prior to Day 1 or plans to receive a vaccination at any time during the treatment period or within 28 days after study Day 28.
Subject has received treatment in another clinical study of an investigational drug (or medical device) or investigational vaccine within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the clinical investigative site).
Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction.
Subject is 20 years of age or older and has a ≥10% risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool: www.mcw.edu/calculators/ldl-cholesterol-goal-level.
Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures.
Subject has a history of a peptic ulcer or significant gastrointestinal bleeding.
Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
Subject has a malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure, or malignancy that is likely to recur during the period of the study (subject should be in complete remission for at least 5 years).
Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator.
Subject has used any of the following prohibited medications from within 7 days (or 5 half lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of cytochromes (CYP)2C8 including repaglinide, paclitaxel, montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject.
Subject has a history of drug or alcohol abuse or dependency within the last year before screening.
Subject has a current or recent (<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.

Where it is running

Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
Advanced Pharma — Miami, Florida, United States
Orlando Clinical Research Center — Orlando, Florida, United States
Meridian Clinical Research — Omaha, Nebraska, United States
Hassman Research Institute — Berlin, New Jersey, United States
High Point Clinical Trials Center — High Point, North Carolina, United States
Midwest Clinical Research Center — Dayton, Ohio, United States
Coastal Carolina Research Center — North Charleston, South Carolina, United States
PPD Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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