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Journal of Drug Assessment Volume 7, 2018 - Issue 1
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Infectious Disease

A first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study to assess the safety, tolerability, and pharmacokinetics of BZF961 with and without ritonavir in healthy adult volunteers

Stephen YoungbergCelerion, Lincoln, NE, USA;
,
Erin BrandtCelerion, Lincoln, NE, USA;
,
Avantika BarveNovartis Institutes for BioMedical Research, East Hanover, NJ, USA;
,
Surendra MachineniNovartis Healthcare Private Limited, Hyderabad, India;
,
Christopher T. JonesNovartis Institutes for BioMedical Research, Emeryville, CA, USA;
,
Kristina DabovicNovartis Institutes for BioMedical Research, East Hanover, NJ, USA;
,
Catherine L. JonesNovartis Institutes for BioMedical Research, Emeryville, CA, USA;
&
Richard A. ColvinNovartis Institutes for BioMedical Research, Cambridge, MA, USACorrespondence[email protected]
 show all
Pages 66-74 | Received 15 Jun 2018, Accepted 09 Oct 2018, Published online: 24 Oct 2018

Figures & data

Figure 1. Structure of BZF961.

Figure 1. Structure of BZF961.

Figure 2. Study design.

Figure 2. Study design.

Table 1. Subject demographics.

Table 2. Number and percentage of subjects with AEs by preferred term (safety analysis set).

Table

Table

Figure 3. Arithmetic mean plasma concentration–time profiles of BZF961 following oral administration of single ascending doses (Part 1). BZF961 10 mg (^), 30 mg (Δ), 100 mg ( □ ), 300 mg (⋄), and 1000 mg (*).

Figure 3. Arithmetic mean plasma concentration–time profiles of BZF961 following oral administration of single ascending doses (Part 1). BZF961 10 mg (^), 30 mg (Δ), 100 mg ( □ ), 300 mg (⋄), and 1000 mg (*).

Table 3. Summary statistics of BZF961 pharmacokinetic parameters by treatment (pharmacokinetic analysis set).

Table

Table

Figure 4. Arithmetic mean plasma concentration-time profiles of BZF961 following oral administration of multiple ascending doses on Day 7 (Part 2). BZF961 100 mg q 8 h (^), 300 mg q 8 h (Δ), and 500 mg q 8 h ( □ ).

Figure 4. Arithmetic mean plasma concentration-time profiles of BZF961 following oral administration of multiple ascending doses on Day 7 (Part 2). BZF961 100 mg q 8 h (^), 300 mg q 8 h (Δ), and 500 mg q 8 h ( □ ).

Figure 5. Arithmetic mean plasma concentration–time profiles of BZF961 following oral administration of BZF961 alone or in combination with ritonavir (Part 3). BZF961 50 mg alone (^), BZF961 50 mg + three doses of ritonavir (Δ), BZF961 10 mg alone ( □ ), BZF961 10 mg + three doses of ritonavir (⋄), BZF961 50 mg alone (*) and BZF961 50 mg + single dose of ritonavir (♣).

Figure 5. Arithmetic mean plasma concentration–time profiles of BZF961 following oral administration of BZF961 alone or in combination with ritonavir (Part 3). BZF961 50 mg alone (^), BZF961 50 mg + three doses of ritonavir (Δ), BZF961 10 mg alone ( □ ), BZF961 10 mg + three doses of ritonavir (⋄), BZF961 50 mg alone (*) and BZF961 50 mg + single dose of ritonavir (♣).

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