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

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Brief Title

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

Official Title

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

Brief Summary

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

Detailed Description

      A postmarketing open-label, 5 period crossover, drug-drug interaction study of orally
      administered TPOXX when coadministered with 4 different phosphate binders in healthy adult
      subjects.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Plasma PK Parameter for TPOXX

Secondary Outcome

 Safety of 600 mg oral TPOXX administered with 4 different phosphate binders

Condition

Smallpox

Intervention

TPOXX

Study Arms / Comparison Groups

 ABCDE
Description:  Single oral dose of TPOXX 600 mg
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

September 15, 2021

Completion Date

September 19, 2022

Primary Completion Date

September 19, 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dennis Hruby, PhD, 541-246-4367, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04485039

Organization ID

SIGA-246-023


Responsible Party

Sponsor

Study Sponsor

SIGA Technologies

Collaborators

 Biomedical Advanced Research and Development Authority

Study Sponsor

Dennis Hruby, PhD, Study Director, SIGA Technologies Chief Scientific Officer


Verification Date

May 2020