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

• Status: Not yet recruiting
• Trial end date: 2023-01-19
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, drug-drug interaction study with TPOXX and phosphate binders.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SIGA Technologies
• Collaborators: Biomedical Advanced Research and Development Authority; PPD
• Treatments: Calcium acetate; Sevelamer

Criteria

Inclusion Criteria:

• Each subject must meet all of the following criteria to be enrolled in this study:

1. Subject is male or female 18 to 50 years of age, inclusive.

2. Phosphorus levels within normal laboratory reference range.

3. Women of childbearing potential have a negative human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 of each period before receipt of study drug, and meet one of the following criteria:

1. The subject or their partner has undergone surgical sterilization

2. 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

3. The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)

4. 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:

i. Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after last dose of study drug 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 has undergone a vasectomy at least 3 months before screening.

4. 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.

5. Subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.

6. Subject agrees to comply with the dietary requirements.

7. Subject agrees to comply with all protocol requirements.

8. Subject is able to provide written informed consent.