Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers

NCT03817346 | Completed Phase 1 DMC

• 1 other identifier: GAB-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers. A longer-term objective is to apply the findings from this study to design and later conduct a clinical development programme of GT-002 as a medication to treat schizophrenia.

Conditions

Safety and Tolerability

Keywords

Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs

  Day 1 to day 3

Secondary Outcomes (6)

• Pharmacokinetic parameter AUCt

  Day1 to day 3

• Pharmacokinetic parameter AUC0-24

  Day1 to day 2

• Pharmacokinetic parameter AUC0-infinity

  day 1 to day 3

• Pharmacokinetic parameter Cmax

  Day 1 to day 3

• tmax

  Day 1 to day 3

Study Arms (2)

Experimental GT-002 SAD

ACTIVE COMPARATOR

Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002.

Drug: GT-002

Experimental Placebo oral capsule SAD

PLACEBO COMPARATOR

Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002.

Drug: Placebo oral capsule

Interventions

GT-002 DRUG

Single ascending dose

Experimental GT-002 SAD

Placebo oral capsule DRUG

Comparator single ascending dose

Experimental Placebo oral capsule SAD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is willing and able to give written informed consent for participation in the study. Sufficient command of the Finnish language will be needed for informed consent and adequate communication with the study personnel.
• Healthy male subjects from 18 up to 45 years of age.
• Body mass index (BMI) from 18 kg/m2 up to 28 kg/m2.
• Body weight from 60 kg up to 120 kg.
• Clinically normal medical history, physical findings, vital signs, ECG and laboratory values as judged by the investigator at the time of the screening visit. A subject with a clinical abnormality or laboratory parameters outside of the reference range for the population being studied may be included at the investigator´s discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures.
• Subjects must be willing to use condom or other contraceptive methods with a failure rate of \< 1% and refrain from donating sperm from the date of dosing until one month after last dosing.

You may not qualify if:

• Current or history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
• History of any type of cancer.
• Subjects considered unlikely to comply with study procedures, restrictions and requirements
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures
• Any clinically significant abnormalities in clinical chemistry, haematology, coagulation or urinalysis results at the time of screening visit as judged by the investigator
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV)
• After 10 minutes of supine rest, abnormal vital signs defined as any of the following:
• Systolic blood pressure \> 140 mm Hg (average of two measurements)
• Diastolic blood pressure \> 90 mm Hg (average of two measurements)
• Heart rate \< 40 or \> 85 beats per minute (average of two measurements)
• Body temperature (auricular) ≥38oC
• Prolonged QTcF interval (\>450 ms), clinically significant cardiac arrhythmia or any other clinically significant abnormalities in the resting ECG as judged by the investigator
• Intake of any medication, vitamin or mineral supplement product that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times the half-life of the medication. Possible prior use of enzyme inducing drugs will be considered case-by-case by the investigator.
• Any blood donation/blood loss \> 250 ml during the 3 months prior to screening
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the administration of investigational product in this study. Subjects consented and screened but not dosed in previous phase I studies can be included in this study.

Sponsors & Collaborators

• Gabather AB: lead
• Smerud Medical Research International AS: collaborator

Study Sites (1)

CRST Oy, Clinical Research Services Turku

Turku, 20520, Finland

Location

Study Officials

• Yvonne Peltonen

  Smerud Medical Research Finland Ab/Oy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinde
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: January 25, 2019
• Study Start: December 17, 2018
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)