PK and food effect study of new formulations of tacrolimus (QCL118062)

• Research type

  Research Study

• Full title

  A Phase I Bioavailability Study in Healthy Caucasian Male and Female Subjects Designed to Evaluate the Pharmacokinetic Profile of Tacrolimus Capsule Formulations and to Assess the Impact of Food

• IRAS ID

  236539

• Contact name

  Santosh Varghese

• Sponsor organisation

  VIVUS Inc.

• Eudract number

  2017-004254-42

• Duration of Study in the UK

  0 years, 3 months, 16 days

• Research summary

  The Sponsor is developing a new formulation (recipe) of an already available medicine, Tacrolimus, for the potential treatment of Pulmonary arterial hypertension (PAH). PAH is a condition of increased blood pressure in the blood vessels that fill the arteries found in the lungs. It is a serious condition that can damage the right side of the heart and can lead to heart failure.\n\nThe study will try to identify the safety, tolerability, pharmacokinetics (how the study drug is taken up by the body) and the effect of food on the pharmacokinetics, of different capsule formulations (recipes) of the study drug in healthy caucasian male and female subjects.\n\nThe study will consist of up to 2 parts (optional Part 2) involving up to 28 healthy caucasian male and female volunteers. In Part 1, a single group of 16 volunteers will receive a dose of the study drug on up to 6 occasions in up to 6 regimens (optional regimens D, E and F). The starting dose is 2.5 mg. A higher dose of study drug may be given in the optional dosing occasions which will be decided based on data collected from previous visits. \n\nThe safety, tolerability and pharmacokinetic data from Part 1 will be reviewed to decide the dose, formulation and if the volunteers will be fed or fasted, for the optional Part 2 of the study. \n\nIf a suitable formulation has been found in Part 1, Part 2 will look at the safety, tolerability and pharmacokinetics of multiple doses of one of the capsule formulations of the study drug from Part 1. A single group of 12 volunteers will receive a dose of the study drug once daily for 7 days. \n

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  18/EE/0007

• Date of REC Opinion

  9 Feb 2018

• REC opinion

  Further Information Favourable Opinion