Trial Outcomes & Findings for Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders (NCT NCT04485039)

NCT ID: NCT04485039

Last Updated: 2024-12-27

Results Overview

Area under the plasma concentration of vs. time curve (AUC) of TPOXX from 0 extrapolated to infinity

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: Day 3
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	TPOXX Co-administered With Phosphate Binders Single oral dose of TPOXX 600 mg, followed by TPOXX co-administered with a single oral dose of each of the following four phosphate binders individually with washout between each period: sevelamer carbonate 1600 mg sucroferric oxyhydroxide chewable tablet 500 mg calcium acetate 1334 mg lanthanum carbonate chewable tablet 500 mg Participants were randomly assigned to receive TPOXX with one of each of the phosphate binders in 1:1:1:1 ratio to maintain enrollment across all periods. The order of administration of TPOXX with each individual phosphate binder had no bearing on study design due to washout between periods.
TPOXX Only STARTED	44
TPOXX Only COMPLETED	41
TPOXX Only NOT COMPLETED	3
TPOXX With Sevelamer Carbonate STARTED	41
TPOXX With Sevelamer Carbonate COMPLETED	39
TPOXX With Sevelamer Carbonate NOT COMPLETED	2
TPOXX With Sucroferric Oxyhydroxide STARTED	39
TPOXX With Sucroferric Oxyhydroxide COMPLETED	39
TPOXX With Sucroferric Oxyhydroxide NOT COMPLETED	0
TPOXX With Calcium Acetate STARTED	39
TPOXX With Calcium Acetate COMPLETED	39
TPOXX With Calcium Acetate NOT COMPLETED	0
TPOXX With Lanthanum Carbonate STARTED	39
TPOXX With Lanthanum Carbonate COMPLETED	39
TPOXX With Lanthanum Carbonate NOT COMPLETED	0

Reasons for withdrawal

Measure	TPOXX Co-administered With Phosphate Binders Single oral dose of TPOXX 600 mg, followed by TPOXX co-administered with a single oral dose of each of the following four phosphate binders individually with washout between each period: sevelamer carbonate 1600 mg sucroferric oxyhydroxide chewable tablet 500 mg calcium acetate 1334 mg lanthanum carbonate chewable tablet 500 mg Participants were randomly assigned to receive TPOXX with one of each of the phosphate binders in 1:1:1:1 ratio to maintain enrollment across all periods. The order of administration of TPOXX with each individual phosphate binder had no bearing on study design due to washout between periods.
TPOXX Only Adverse Event	2
TPOXX Only Physician Decision	1
TPOXX With Sevelamer Carbonate Adverse Event	1
TPOXX With Sevelamer Carbonate Withdrawal by Subject	1

Baseline Characteristics

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Baseline characteristics by cohort

Measure	TPOXX: Oral Antiviral and Phosphate Binders n=44 Participants Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Age, Customized Age	33.5 years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Height (cm)	170.39 centimeters STANDARD_DEVIATION 8.674 • n=5 Participants
Weight (kg)	84.51 kilograms STANDARD_DEVIATION 18.012 • n=5 Participants
Body Mass Index (kg/m2)	29.10 Kilograms Per Square Meter STANDARD_DEVIATION 5.898 • n=5 Participants

PRIMARY outcome

Timeframe: Day 3

Population: healthy participants

Area under the plasma concentration of vs. time curve (AUC) of TPOXX from 0 extrapolated to infinity

Outcome measures

Measure	TPOXX: Oral Antiviral n=44 Participants Single oral dose of TPOXX 600 mg	TPOXX: Oral Antiviral Coadministered With Sevelamer Carbonate n=41 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1600 mg sevelamer carbonate	TPOXX: Oral Antiviral Coadministered With Sucroferric Oxyhydroxide n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet	TPOXX: Oral Antiviral Coadministered With Calcium Acetate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1334 mg calcium acetate	TPOXX: Oral Antiviral Coadministered With Lanthanum Carbonate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet
AUC0-inf	16300 ng*h/mL Geometric Coefficient of Variation 39.6	21600 ng*h/mL Geometric Coefficient of Variation 46.4	21000 ng*h/mL Geometric Coefficient of Variation 37.8	19500 ng*h/mL Geometric Coefficient of Variation 37.4	21000 ng*h/mL Geometric Coefficient of Variation 25.9

PRIMARY outcome

Timeframe: Day 3

Population: healthy participants

Cmax - maximum observed plasma concentration of TPOXX

Outcome measures

Measure	TPOXX: Oral Antiviral n=44 Participants Single oral dose of TPOXX 600 mg	TPOXX: Oral Antiviral Coadministered With Sevelamer Carbonate n=41 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1600 mg sevelamer carbonate	TPOXX: Oral Antiviral Coadministered With Sucroferric Oxyhydroxide n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet	TPOXX: Oral Antiviral Coadministered With Calcium Acetate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1334 mg calcium acetate	TPOXX: Oral Antiviral Coadministered With Lanthanum Carbonate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet
Cmax	1230 ng/mL Geometric Coefficient of Variation 29.5	1440 ng/mL Geometric Coefficient of Variation 29.6	1440 ng/mL Geometric Coefficient of Variation 32.7	1370 ng/mL Geometric Coefficient of Variation 32.0	1510 ng/mL Geometric Coefficient of Variation 26.1

SECONDARY outcome

Timeframe: 59 days

Population: Healthy participants

Number of participants with adverse events when TPOXX is coadministered with phosphate binders

Outcome measures

Measure	TPOXX: Oral Antiviral n=44 Participants Single oral dose of TPOXX 600 mg	TPOXX: Oral Antiviral Coadministered With Sevelamer Carbonate n=41 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1600 mg sevelamer carbonate	TPOXX: Oral Antiviral Coadministered With Sucroferric Oxyhydroxide n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet	TPOXX: Oral Antiviral Coadministered With Calcium Acetate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 1334 mg calcium acetate	TPOXX: Oral Antiviral Coadministered With Lanthanum Carbonate n=39 Participants A single oral dose of 600 mg TPOXX coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet
Adverse Events	6 participants	7 participants	7 participants	3 participants	2 participants

Adverse Events

TPOXX: Oral Antiviral

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

TPOXX: Oral Antiviral and Sevelamer Carbonate

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

TPOXX: Oral Antiviral and Sucroferric Oxyhydroxide

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

TPOXX: Oral Antiviral and Calcium Acetate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

TPOXX: Oral Antiviral and Lanthanum Carbonate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	TPOXX: Oral Antiviral n=44 participants at risk Single oral dose of TPOXX 600 mg	TPOXX: Oral Antiviral and Sevelamer Carbonate n=41 participants at risk Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate	TPOXX: Oral Antiviral and Sucroferric Oxyhydroxide n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet	TPOXX: Oral Antiviral and Calcium Acetate n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate	TPOXX: Oral Antiviral and Lanthanum Carbonate n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Infections and infestations Urinary tract infection	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed

Other adverse events

Measure	TPOXX: Oral Antiviral n=44 participants at risk Single oral dose of TPOXX 600 mg	TPOXX: Oral Antiviral and Sevelamer Carbonate n=41 participants at risk Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate	TPOXX: Oral Antiviral and Sucroferric Oxyhydroxide n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet	TPOXX: Oral Antiviral and Calcium Acetate n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate	TPOXX: Oral Antiviral and Lanthanum Carbonate n=39 participants at risk Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Nervous system disorders Headache	4.5% 2/44 • Number of events 2 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	4.9% 2/41 • Number of events 2 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	5.1% 2/39 • Number of events 2 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	7.7% 3/39 • Number of events 3 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Nervous system disorders Dizziness	4.5% 2/44 • Number of events 2 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Nervous system disorders Somnolence	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Gastrointestinal disorders Nausea	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Gastrointestinal disorders Vomiting	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Gastrointestinal disorders Diarrhoea	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Gastrointestinal disorders Dry mouth	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Musculoskeletal and connective tissue disorders Back pain	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
General disorders Fatigue	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
General disorders Feeling hot	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Infections and infestations Tinea pedis	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Injury, poisoning and procedural complications Bum oral cavity	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Injury, poisoning and procedural complications Concussion	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Skin and subcutaneous tissue disorders Acne	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Eye disorders Eyelid irritation	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Investigations SARS-CoV-2 test positive	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Psychiatric disorders Nervousness	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.4% 1/41 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.3% 1/44 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed
Social circumstances Physical assault	0.00% 0/44 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/41 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	2.6% 1/39 • Number of events 1 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed	0.00% 0/39 • Adverse event data was collected from Day 1 though the Day 59 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor. All-Cause Mortality was not assessed

Additional Information

Emily Blum, Director of Clinical Development

SIGA Technologies

Phone: 541-224-1305

Email: eblum@siga.com

Results disclosure agreements

• Principal investigator is a sponsor employee The agreement restricts the right of the PI to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER