A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.

Launched by ASTRAZENECA · Dec 1, 2022

Keywords

ClinConnect Summary

This study will be an open-label, randomised, crossover study in healthy participants (males and females of non-childbearing potential).

The study will comprise two parts: Part A and Part B.

The study will include a screening period of 28 days for both Part A and Part B.

Part A will be a 3-period (Periods 1, 2, 3), 3-treatment (Treatments A, B, C) crossover study, performed at a single clinical unit. During the 3 periods (Periods 1, 2, 3) participants will participate from Day -1 of Period 1 to 72 hours after the nintedanib dose in Period 3. In each period, the participants will receive ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy nonsmoking male and female (of non-childbearing potential) participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
• • 2. Females must have a negative pregnancy test, must not be lactating and must be of non childbearing potential.
• • 3. Male participants and their woman partners of childbearing potential must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child.
• Exclusion Criteria:
• • 1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• • 2. History or presence of chronic gastrointestinal, hepatic, or renal disease, any acute disease in these organs, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• • 3. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP (Investigational Medicinal Product).
• • 4. Untreated TB (Tuberculosis) or a positive result for the IGRA (Interferon Gamma Release Assay) (ie, QuantiFERON TB Gold).
• • 5. Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) .
• • 6. History of severe COVID-19 (corona virus) infection requiring hospitalisation within the last 12 months prior to Screening, or clinical history compatible with Long COVID-19 (symptoms beyond 12 weeks of acute infection).
• • 7. Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID-19 vaccine within 30 days prior to randomisation, or a COVID-19 vaccine second or booster vaccination within 10 days of Screening.
• • 8. History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
• • 9. History of a traumatic fracture within 6 months of Screening.
• 10. Any laboratory values with the following deviations:
• • (1) Alanine aminotransferase \> ULN (2) Aspartate aminotransferase \> ULN (3) Total bilirubin \> ULN (4) White blood cell count \< 3.5 × 109/L (5) Platelet \< LLN (6) eGFR \< 90 ml/min/1.73 m2 (Cockroft-Gault or CKD-EPI formula) 11. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (Electrocardiogram) and any clinically important abnormalities in the 12-lead ECG .
• • 12. Any positive result on Screening for active hepatitis A, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibody, or any known chronic/active liver diseases.
• • 13. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5055 or nintedanib.
• • 14. Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
• • 15. Subjects who have previously received AZD5055.