A Safety, Tolerability, PK and Taste Study of Tecovirimat (QSC204654)

• Research type

  Research Study

• Full title

  A Phase 1, Single-Centre, Open Label, Up to Two-Part, Single Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Effect of Refrigerated Storage and Taste of Tecovirimat Paediatric Formulation Prototype(s) for Oral Suspension in Healthy Adult Subjects

• IRAS ID

  297196

• Contact name

  Paul Long

• Contact email

  plong@siga.com

• Sponsor organisation

  SIGA Technologies, Inc.

• Eudract number

  2021-002866-42

• ISRCTN Number

  ISRCTN13846827

• Duration of Study in the UK

  0 years, 7 months, 0 days

• Research summary

  Summary of Research
  The Sponsor is developing a new test medicine to treat smallpox in children and babies who weigh less than 13 kg (around 2 stone).

  Smallpox is an infectious disease, caused by variola virus (VARV), which belongs to a group of viruses called Orthopoxvirus.

  The medicine TPOXX® (tecovirimat), was approved in 2018 by the Food and Drug Administration in the United States and is available for use to treat smallpox in the form of a capsule, but cannot currently be given to patients who weigh less than 13 kg. Therefore, the Sponsor is developing a new form of tecovirimat, so that it can be given to babies and children.

  This study will aim to assess the Pharmacokinetics (PK, how the test medicine is taken up by the body), relative bioavailability (how much drug is absorbed into the body), safety, tolerability and taste of the test medicine.

  There may be up to 2 parts to this study, with two optional study designs for Part 2. The results from Part 1 will determine whether Part 2 will take place, and which study design will be used.

  Part 1 will investigate how the test medicine is taken up by the body when taken as a powder that is mixed with water, after eating a medium fat breakfast. Two different recipes will be investigated and will be compared to the approved medicine, TPOXX® capsules.

  If utilised, Parts 2a and 2b will both investigate the impact of refrigerated storage on the test medicine, how well the test medicine is taken up by the body when given in the fed and fasted state and when compared to the approved medicine, TPOXX® capsules. Part 2a will test up to four different recipes of the test medicine whereas 2b will test one of the recipes from Part 1, depending on results.

  Summary of Results
  No lay summary of results is available, however top-level information on adverse events and other data is available on ISRCTN.
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• REC name

  Wales REC 2

• REC reference

  21/WA/0262

• Date of REC Opinion

  21 Sep 2021

• REC opinion

  Favourable Opinion