BOS-356 News - LARVOL Sigma

||||||||||  BOS-356 / GSK, Boston Pharma
Trial completion, Trial completion date, Trial primary completion date:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) -  Nov 26, 2020
P1, N=66, Completed,  Sponsor: Boston Pharmaceuticals
Recruiting --> Completed | Trial completion date: May 2021 --> Nov 2020 | Trial primary completion date: May 2021 --> Nov 2020

||||||||||  BOS-356 / GSK, Boston Pharma
Trial completion date, Trial primary completion date:  Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) -  Oct 4, 2020
P1, N=66, Recruiting,  Sponsor: Boston Pharmaceuticals
Recruiting --> Completed | Trial completion date: May 2021 --> Nov 2020 | Trial primary completion date: May 2021 --> Nov 2020 Trial completion date: Aug 2020 --> May 2021 | Trial primary completion date: Aug 2020 --> May 2021

|||||||||| BOS-356 / Boston Pharma, GSK
Clinical, P1 data, PK/PD data, Journal: First-in-Human Pharmacokinetics and Safety Study of GSK3008356, a Selective DGAT1 Inhibitor, in Healthy Volunteers. (Pubmed Central) - Aug 19, 2020
Exposure of GSK3008356 was largely dose proportional after RDs. At higher doses, there was a trend toward lower absolute postprandial TG level in some subjects.

|||||||||| BOS-356 / Boston Pharma, GSK
Clinical, Journal: A Population Analysis of the DGAT1 Inhibitor GSK3008356 and its Effect on Endogenous and Meal-Induced Triglyceride Turnover in Healthy Subjects. (Pubmed Central) - Apr 10, 2020
The current analysis presents a PKPD modeling strategy of time-varying TG data coming from both endogenous and exogenous sources. In general, the presented model could be utilized in the model-based drug development of drugs that influence TG levels in blood.

||||||||||  BOS-356 / GSK, Boston Pharma
Enrollment change:  Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects (clinicaltrials.gov) -  Aug 10, 2017
P1, N=104, Completed,  Sponsor: GlaxoSmithKline
In general, the presented model could be utilized in the model-based drug development of drugs that influence TG levels in blood. N=80 --> 104

||||||||||  BOS-356 / GSK, Boston Pharma
Trial completion, Enrollment change:  Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects (clinicaltrials.gov) -  Jul 13, 2017
P1, N=80, Completed,  Sponsor: GlaxoSmithKline
N=80 --> 104 Recruiting --> Completed | N=142 --> 80

||||||||||  BOS-356 / GSK, Boston Pharma
Enrollment change, Trial primary completion date:  Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects (clinicaltrials.gov) -  Sep 9, 2016
P1, N=142, Recruiting,  Sponsor: GlaxoSmithKline
Recruiting --> Completed | N=142 --> 80 N=94 --> 142 | Trial primary completion date: Nov 2016 --> May 2017



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