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

NCT ID: NCT03919890

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2019-08-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blinded

Study Groups

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ONO-7684 Part A1

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

Group Type EXPERIMENTAL

ONO-7684

Intervention Type DRUG

Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3

ONO-7684 Placebo Part A1

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

Group Type PLACEBO_COMPARATOR

ONO-7684 Placebo

Intervention Type DRUG

Placebo comparator

ONO-7684 Part A2

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

Group Type EXPERIMENTAL

ONO-7684

Intervention Type DRUG

Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3

ONO-7684 Placebo Part A2

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

Group Type PLACEBO_COMPARATOR

ONO-7684 Placebo

Intervention Type DRUG

Placebo comparator

ONO-7684 Part B1

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

Group Type EXPERIMENTAL

ONO-7684

Intervention Type DRUG

Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3

ONO-7684 Placebo Part B1

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

Group Type PLACEBO_COMPARATOR

ONO-7684 Placebo

Intervention Type DRUG

Placebo comparator

Interventions

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ONO-7684

Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3

Intervention Type DRUG

ONO-7684 Placebo

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hammersmith Medicines Research (HMR)

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ONO-7684-01

Identifier Type: -

Identifier Source: org_study_id