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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Venous Thromboembolism

Treatments: Drug: ONO-7684; Drug: ONO-7684 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03919890

ONO-7684-01

Details and patient eligibility

About

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-7684 in healthy adult volunteers. This study will be conducted in 2 parts: Part A is a single-ascending dose and Part B is a multiple-ascending dose.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 6 patient groups, including a placebo group

ONO-7684 Part A1

Experimental group

Description:

Single ascending doses of ONO-7684 or placebo orally under fasted conditions

Treatment:

Drug: ONO-7684

ONO-7684 Placebo Part A1

Placebo Comparator group

Description:

Single ascending doses of ONO-7684 or placebo orally under fasted conditions

Treatment:

Drug: ONO-7684 Placebo

ONO-7684 Part A2

Experimental group

Description:

Single doses of ONO-7684 or placebo orally under fed conditions

Treatment:

Drug: ONO-7684

ONO-7684 Placebo Part A2

Placebo Comparator group

Description:

Single doses of ONO-7684 or placebo orally under fed conditions

Treatment:

Drug: ONO-7684 Placebo

ONO-7684 Part B1

Experimental group

Description:

Eligible subjects will receive multiple doses of ONO-7684 or placebo orally

Treatment:

Drug: ONO-7684

ONO-7684 Placebo Part B1

Placebo Comparator group

Description:

Eligible subjects will receive multiple doses of ONO-7684 or placebo orally

Treatment:

Drug: ONO-7684 Placebo