NCT04504760

Brief Summary

To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2020

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

July 31, 2020

Last Update Submit

May 2, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Adverse events [Safety and Tolerability]

    Number of participants with adverse events as assessed by CTCAE v5.0

    Up to 13 days

Secondary Outcomes (9)

  • Cmax [Pharmacokinetic]

    Up to 10 days

  • Tmax [Pharmacokinetic]

    Up to 10 days

  • AUC24h [Pharmacokinetic]

    Up to 10 days

  • AUClast [Pharmacokinetic]

    Up to 10 days

  • AUCinf [Pharmacokinetic]

    Up to 10 days

  • +4 more secondary outcomes

Study Arms (4)

ONO-2910 (Part A and B)

EXPERIMENTAL
Drug: ONO-2910

Placebo (Part A)

PLACEBO COMPARATOR
Drug: Placebo

ONO-2910 (Part C and D)

EXPERIMENTAL
Drug: ONO-2910

Placebo (Part C and D)

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ONO-2910DRUG

Single ascending dose of ONO-2910 will be administered orally.

ONO-2910 (Part A and B)
PlaceboDRUG

Single dose of placebo will be administered orally.

Placebo (Part A)

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese healthy adult male subjects (Part A and C)
  • Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
  • Caucasian healthy adult male subjects (Part D)
  • Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

You may not qualify if:

  • Subjects currently with or with a history of disease
  • Subjects with current or with a history of severe allergy to drugs or foods
  • Subjects with current or with a history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Clinical Site 01

Tokyo, Japan

Location

Study Officials

  • Masaharu Komeno

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 7, 2020

Study Start

July 10, 2020

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)