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

NCT03919890 | Completed Phase 1

• 1 other identifier: ONO-7684-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (6)

• Number of participants with clinically significant changes in vital signs (Part A & B)

  Pulse rate (bpm), systolic and diastolic blood pressure (mmHg), Respiratory rate (bpm)

  Part A: Day 1-4 & Follow-up and Part B: Day 1-15, 17 & Follow up

• Number of participants with clinically significant changes observed on 12-lead electrocardiogram (ECG) (Part A & B)

  Ventricular rate (beats/min), PR interval (msec), QRS interval (msec), QT (msec), QTcF interval (msec)

  Part A: Day 1-4 & Follow up & Part B: Day 1,3,5,7,9,11,14,17 & Follow up

• Number of participants with clinically significant changes in cardiac telemetry (Part A only)

  Number of participants with cardiac telemetry abnormalities will be reported.

  Part A: From 0.5-1 hours pre-dose until 12 hours after dosing at Day 1

• Number of participants with clinically significant changes in physical examination (Part A & B)

  Number of participants with physical examination abnormalities will be reported.

  Part A: Day -1, 1-4 & Follow-up and Part B: Day-1, 1-17 & Follow up

• Number of participants with clinically significant changes in laboratory safety tests (haematology, biochemistry and urinalysis) (Part A & B)

  Number of participants with abnormalities in laboratory safety tests will be reported.

  Part A: Day-1, 1-4 & Follow up and Part B: Day-1, 1-17 & Follow up

• Number of participants with adverse events (AE) (Part A & B)

  AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Part A: Day-1, 1-4 & Follow up and Part B: Day-1, 1-17 & Follow up

Secondary Outcomes (21)

• Pharmacokinetics (Cmax)

  Part A: Day 1 through Day 4. Part B: Day 1 and Day 14

• Pharmacokinetics (tmax)

  Part A: Day 1 through Day 4. Part B: Day 1 and Day 14

• Pharmacokinetics (AUClast)

  Part A: Day 1 through Day 4. Part B: Day 14

• Pharmacokinetics (AUCinf)

  Part A: Day 1 through Day 4. Part B: Day 14

• Pharmacokinetics (AUCt)

  Part A: Day 1 through Day 4. Part B: Day 1

Study Arms (6)

ONO-7684 Part A1

EXPERIMENTAL

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

Drug: ONO-7684

ONO-7684 Placebo Part A1

PLACEBO COMPARATOR

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

Drug: ONO-7684 Placebo

ONO-7684 Part A2

EXPERIMENTAL

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

Drug: ONO-7684

ONO-7684 Placebo Part A2

PLACEBO COMPARATOR

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

Drug: ONO-7684 Placebo

ONO-7684 Part B1

EXPERIMENTAL

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

Drug: ONO-7684

ONO-7684 Placebo Part B1

PLACEBO COMPARATOR

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

Drug: ONO-7684 Placebo

Interventions

ONO-7684 DRUG

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

ONO-7684 Part A1; ONO-7684 Part A2; ONO-7684 Part B1

ONO-7684 Placebo DRUG

Placebo comparator

ONO-7684 Placebo Part A1; ONO-7684 Placebo Part A2; ONO-7684 Placebo Part B1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• normotensive male volunteers, or female volunteers of non-childbearing potential (Part B only)
• body mass index 18.0-30.0 kg/m2
• deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
• registered with a General Practitioner (GP) in the UK
• agree to use an effective method of contraception
• able to give fully informed written consent

You may not qualify if:

• Positive tests for hepatitis B \& C, HIV
• severe adverse reaction to any drug
• sensitivity to trial medication
• drug or alcohol abuse
• current smoker or use of nicotine containing products in the previous 6 months
• vegetarians or vegans, or unwilling to eat a high-fat breakfast (Part A food effect cohorts only)
• 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
• prescription or over-the-counter medication, vitamins, herbal treatments or dietary supplements within the previous 7 days (with the exception of paracetamol \[acetaminophen\])
• 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
• vital signs outside the acceptable range
• clinically relevant abnormal findings at the screening assessment (including creatinine clearance, haemoglobin levels and QTcF)
• acute or chronic illness
• clinically relevant abnormal medical history or concurrent medical condition
• objection by GP
• possibility that volunteer will not cooperate

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: April 18, 2019
• Study Start: January 17, 2019
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

GB (1)