NCT04364789

Brief Summary

This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_1 healthy

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

February 5, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

April 21, 2020

Last Update Submit

February 24, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Numbers of Treatment Emergent Adverse Events(TEAE)

    Safety and tolerability of TT-00920

    10 days

  • Number of participants with Abnormal Laboratory Values

    Safety and tolerability of TT-00920

    10 days

  • Area under the plasma drug concentration versus time curve

    PK parameters of TT-00920

    10 days

  • Maximum Observed Plasma Concentration (Cmax)

    PK parameters of TT-00920

    10 days

  • Time of First Occurrence of Cmax （tmax) Time of first Occurance of Cmax（tmax)

    PK parameters of TT-00920

    10 days

  • Terminal half-life (t1/2)

    PK parameters of TT-00920

    10 days

  • Elimination rate (λz)

    PK parameters of TT-00920

    10 days

  • Volume of distribution (Vz/F)

    PK parameters of TT-00920

    10 days

  • Clearance (CL/F)

    PK parameters of TT-00920

    10 days

Secondary Outcomes (7)

  • Area under the plasma drug concentration versus time curve

    10 days

  • Maximum Observed Plasma Concentration (Cmax)

    10 days

  • Time of first Occurance of Cmax（tmax)

    10 days

  • Terminal half-life (t1/2)

    10 days

  • Elimination rate (λz)

    10 days

  • +2 more secondary outcomes

Other Outcomes (2)

  • Metabolite characterization in plasma and estimation of observed drug-related material in plasma to determine the presence of any metabolite >10%

    10 days

  • Cyclic guanosine monophosphate (cGMP) levels in plasma and urine

    10days

Study Arms (7)

Pilot dose Cohort

ACTIVE COMPARATOR

A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.

Drug: TT-00920

SAD Dose 1

ACTIVE COMPARATOR
Drug: TT-00920

SAD Dose 2

ACTIVE COMPARATOR
Drug: TT-00920

SAD Dose 3

ACTIVE COMPARATOR
Drug: TT-00920

SAD Dose 4

ACTIVE COMPARATOR
Drug: TT-00920

Food Effect Cohort

ACTIVE COMPARATOR
Drug: TT-00920

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

TT-00920DRUG

Tablets

Food Effect CohortPilot dose CohortSAD Dose 1SAD Dose 2SAD Dose 3SAD Dose 4
PlacebosDRUG

Tablets

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed.
  • Age ≥ 18 years and ≤ 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone \[FSH\] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).
  • Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.
  • No clinically significant findings in medical examination

You may not qualify if:

  • Any history of clinically serious disease.
  • Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
  • Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test
  • Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests \[color discrimination (Ishihara test) and visual acuity (Snellen chart).
  • Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Phase Clinical Unit Glendale Adventist Medical Center

Los Angeles, California, 91206, United States

Location

Study Officials

  • Gevorkyan Hakop, MD

    Early Phase Clinical Unit Glendale Adventist Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Paticipant, Investigator)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 28, 2020

Study Start

February 5, 2020

Primary Completion

June 18, 2021

Study Completion

March 17, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)