A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers

Launched by ONO PHARMACEUTICAL CO. LTD · Apr 15, 2019

Keywords

ClinConnect Summary

This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when ONO-7684 is administered orally as single doses and as multiple doses to healthy subjects. The study will consist of 2 parts: A single ascending dose (SAD) phase (Part A); a multiple ascending dose (MAD) phase (Part B). One cohort of Part A will receive ONO-7684 under both fasted and fed conditions to investigate the effect of food.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-55 years
• • 2. normotensive male volunteers, or female volunteers of non-childbearing potential (Part B only)
• • 3. body mass index 18.0-30.0 kg/m2
• • 4. deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
• • 5. registered with a General Practitioner (GP) in the UK
• • 6. agree to use an effective method of contraception
• • 7. able to give fully informed written consent
• Exclusion Criteria:
• • 1. Positive tests for hepatitis B \& C, HIV
• • 2. severe adverse reaction to any drug
• • 3. sensitivity to trial medication
• • 4. drug or alcohol abuse
• • 5. current smoker or use of nicotine containing products in the previous 6 months
• • 6. vegetarians or vegans, or unwilling to eat a high-fat breakfast (Part A food effect cohorts only)
• • 7. use of strong CYP3A4/5 or P-glycoprotein inhibitors or inducers, anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid within the previous 30 days
• • 8. prescription or over-the-counter medication, vitamins, herbal treatments or dietary supplements within the previous 7 days (with the exception of paracetamol \[acetaminophen\])
• • 9. participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months or plan to donate blood or blood products in the 3 months after the trial
• • 10. vital signs outside the acceptable range
• • 11. clinically relevant abnormal findings at the screening assessment (including creatinine clearance, haemoglobin levels and QTcF)
• • 12. acute or chronic illness
• • 13. clinically relevant abnormal medical history or concurrent medical condition
• • 14. objection by GP
• • 15. possibility that volunteer will not cooperate
• • 16. pre-menopausal females who are pregnant or lactating, or who are of childbearing potential