NCT02858973

Brief Summary

This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2016

Longer than P75 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

First Submitted

Initial submission to the registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
Last Updated

May 14, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

August 1, 2016

Last Update Submit

May 11, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring

    16 days post dose

Secondary Outcomes (3)

  • Pharmacokinetic analysis: Area under the curve

    16 days post dose

  • Pharmacokinetic analysis: Maximum observed plasma drug concentration

    16 days post dose

  • Pharmacokinetic analysis: Time of maximum observed concentration

    16 days post dose

Study Arms (2)

Q203

EXPERIMENTAL

Q203 tablets

Drug: Q203

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Interventions

Q203DRUG
Q203
PlaceboDRUG
Placebo

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
  • Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.

You may not qualify if:

  • Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  • History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

telacebec

Study Design

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

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 8, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 8, 2018

Last Updated

May 14, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)