A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers

Sponsor

Qurient Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02858973

Collaborator

(none)

Enrollment

Location

Arms

21.2

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Q203 Drug: Placebo	Phase 1

Detailed Description

Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.

Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.

Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Q203 Q203 tablets	Drug: Q203
Placebo Comparator: Placebo Placebo tablets	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Q203

Q203 tablets

Drug: Q203

Placebo Comparator: Placebo

Placebo tablets

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring [16 days post dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

Qurient Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qurient Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02858973

Other Study ID Numbers:

Q203-TB-PI-US002

First Posted:

Aug 8, 2016

Last Update Posted:

May 14, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of May 14, 2018