A Dose Escalating Study to Assess the Safety and Tolerability of GT-001
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|ClinicalTrials.gov Identifier: NCT03490786|
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Feeding and Eating Disorders||Drug: GT-001||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||dose escalation|
|Masking:||None (Open Label)|
|Official Title:||A Dose Escalating Study to Assess the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Lingual Application of GT-001 in Subjects With Obesity.|
|Actual Study Start Date :||July 16, 2017|
|Actual Primary Completion Date :||August 9, 2017|
|Actual Study Completion Date :||October 2, 2017|
Experimental: Dose escalation
Single arm dose escalation.
PK, PD Study to Determine Safety of Escalating Doses of GT-001
- Demonstrate safe doses of PGT-001 for reduction of body weight in obese volunteers. [ Time Frame: approximately two weeks ]Measures of the safety and tolerability of GT-001 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, and laboratory tests.
- Dose-relationship of adverse events [ Time Frame: approximately two weeks ]Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
- Dose relationship to peak plasma concentration of GT-001 [ Time Frame: Approximately two weeks ]Peak plasma concentration of GT-001 to assess relationship to dose of GT-001.
- Dose relationship to hunger and satiety [ Time Frame: approximately two weeks ]Measurement of hunger and satiety will be conducted using visual analog scores to assess a relationship to dose of GT-001
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490786
|United States, California|
|Orange County Research Center|
|Tustin, California, United States, 92780|