CompletedPhase 4

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

United States34 participantsStarted 2019-07-19

Plain-language summary

Safety and PK study in adults weighing more than 120 kg

Who can participate

Age range20 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is male or female between 18 and 50 years of age, inclusive.
✓. Subject has a body weight \>120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.
✓. Women of childbearing potential, have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:
✓. The subject or their partner has undergone surgical sterilization
✓. The 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
✓. The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)
✓. The 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:
✓. 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.

Exclusion criteria

✕. 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:
✕. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
✕. Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
✕. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or excipients, or any significant food allergy that could preclude a standard diet in the study 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).

What they're measuring

AUC0-t

Timeframe: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).

AUC0-24

Timeframe: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)

AUC0-inf

Timeframe: Day 7

Cmax

Tmax

Timeframe: Day 7

t1/2

Timeframe: Day 7

CL/F

Timeframe: Day 7

Vd/F

Timeframe: Day 7

Trial details

NCT IDNCT04392739

SponsorSIGA Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-05

Results submitted2021-05-10

View on ClinicalTrials.gov More Smallpox trials

Who can participate

Age range20 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is male or female between 18 and 50 years of age, inclusive.
✓. Subject has a body weight \>120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.
✓. Women of childbearing potential, have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:
✓. The subject or their partner has undergone surgical sterilization
✓. The 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
✓. The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)
✓. The 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:
✓. 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.

Exclusion criteria

✕. 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:
✕. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
✕. Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
✕. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or excipients, or any significant food allergy that could preclude a standard diet in the study 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).

What they're measuring

AUC0-t

AUC0-24

Timeframe: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)

AUC0-inf

Timeframe: Day 7

Cmax

Tmax

Timeframe: Day 7

t1/2

Timeframe: Day 7

CL/F

Timeframe: Day 7

Vd/F

Timeframe: Day 7