Effect Of CB-03-01 On QT Interval In HV After Given In Multiple Doses

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Accept all cookies See cookie policy Glossary Search glossary Effect of CB-03-01 on QT interval in HV after given in multiple doses

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo controlled Phase I study to investigate the effects of systemically absorbed Cortexolone 17α propionate (and its metabolites) on QT interval following repeat topical administration in healthy volunteers.

• IRAS ID

  236944

• Contact name

  Jorg Taubel

• Contact email

  [email protected]

• Sponsor organisation

  Cassiopea S.p.A.

• Eudract number

  2017-003919-18

• Duration of Study in the UK

  0 years, 2 months, 10 days

• Research summary

  Cortexolone 17α-propionate (known also as CB-03-01) is an investigational drug under development for the topical treatment of skin diseases associated with alterations in certain androgenic hormones, such as acne and alopecia. It is being developed simultaneously in two formulations; a cream and a solution. This trial will investigate the use of solution. The development of the solution, having a higher plasma concentration compared to the cream, has created the opportunity to conduct an ECG study with measurable corresponding PK data.

  This trial will assess multiple fixed doses of the drug when applied topically as a solution to exposed areas of skin on the scalp and both thighs. The trial will be conducted with healthy male and female volunteers aged 18 to 40. Subjects will be required to have any hair overlying areas of administration shaved to prevent obstructing absorption of the drug.The primary endpoint will be to investigate any effect of the drug on the heart, but we will also study the overall safety and tolerability, as well as how long CB-03-01 stays in blood (Pharmacokinetics).

  A single cohort of 24 volunteers is planned with twice daily topical dosing with 225mg (3ml) of CB-03-01. Volunteers will be randomised to active drug or placebo in a 3:1 ratio.

  Volunteers will be admitted to the study unit on Day -1, dosed twice daily on Days 1-3 and once on Day 4 (morning dose only). They will be discharged on Day 6 and have a telephone follow-up on Day 14.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/1864

• Date of REC Opinion

  21 Dec 2017

• REC opinion

  Further Information Favourable Opinion

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