Study to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib in Healthy Subjects

• Research type

  Research Study

• Full title

  An Open-Label, Randomized, Three-Period Study in Healthy Subjects to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib

• IRAS ID

  1006735

• Contact name

  Gunilla Wall

• Contact email

  Gunilla.Wall@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2022-003116-84

• Research summary

  The trial is a single centre, open label trial in up to 18 healthy, non-smoking, males and females (of non-childbearing potential) between the ages of 18 and 55 years.

  The medicine to be tested is this trial is a compound called AZD5055. The sponsor is developing the medicine for the treatment of idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILD). Nintedanib is a approved medication to treat patients with IPF and ILDs

  The main purpose of the clinical trial is to investigate whether AZD5055 affects how Nintedanib is taken up, metabolised (chemically broken down), distributed through the body, and cleared from the body (referred to as pharmacokinetics or PK).
  The clinical trial will also assess how safe AZD5055 is and how well it is tolerated when given in combination with itraconazole.
  The trial will comprise of:
  - A screening period of a maximum 28 days
  - Three dosing periods during which participants will be resident for 10 nights from the day before first dosing (Period 1/Day 1) until 3 days after the last dosing (Period 3/Day 4).
  - A final Follow up visit 6 days post the last dosing
  Participants will be allocated into one of 3 planned sequences to receive the clinical trial medicine.
  Sequence 1: Period 1 = Treatment A; Period 2 = Treatment B; Period 3 = Treatment C
  Sequence 2: Period 1 = Treatment B; Period 2 = Treatment C; Period 3 = Treatment A
  Sequence 3: Period 1 = Treatment C; Period 2 = Treatment A; Period 3 = Treatment B
  The doses are as follows:
  -Treatment A - Nintedanib 100 mg soft capsules
  -Treatment B – AZD5055 as 10 mg dose oral suspension + Nintedanib 100 mg soft capsules
  -Treatment C – AZD5055 as 35 mg dose oral suspension + Nintedanib 100 mg soft capsules

  This is not a first-in-human trial as the study medication has been given to humans before in clinical trials.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  22/SC/0403

• Date of REC Opinion

  20 Apr 2023

• REC opinion

  Further Information Favourable Opinion