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Fig. 1 | BMC Pharmacology and Toxicology

Fig. 1

From: A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis

Fig. 1

Study design. Each cohort consisted of 12 participants (volixibat, n = 9; placebo, n = 3); details are shown for the volixibat arm only. Light-grey boxes indicate dose regimen options that were not undertaken. Bold text indicates alterations to planned doses. Cohorts 4 and onwards were each initiated after reviewing results from previous cohorts.*Study days are approximate. Cohort 2 treatment was to begin at least 4 days after cohort 1 treatment; cohort 3 treatment was to start after completion of treatment in cohort 2.†Changed from 80 mg q.d. following review of data from cohorts 1 and 2 to a descending dose titration of 80–40–20 mg q.d. ‡Results from cohorts 1–3 triggered the use of intermediate and reduced doses in cohorts 4 and 5, instead of increased doses. Treatment of an optional second b.i.d. dose cohort was not undertaken. §Treatment of an optional second q.d. or b.i.d. dose titration cohort was not undertaken. AE, adverse event; b.i.d., twice daily; FBA, faecal bile acid; q.d., once daily

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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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