Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:
A Phase 1 Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, PPI Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects

Status Completed

Clinical Trial Summary

Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following oral administration of 3 prototype formulations in healthy participants compared to an immediate release capsule formulation (reference), and also to determine the relative bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states. Part 2 of the study will be conducted to provide additional information on the safety and tolerability of escalating single doses of the selected formulation of BOS172767 in healthy participants, to evaluate the PK profile following increased single doses of the selected formulation of BOS172767 following administration in healthy participants, and also to evaluate the dose linearity of the selected prototype. Part 3 of the study will be conducted to provide additional information on the safety, tolerability, and PK of the selected formulation of BOS172767 following multiple ascending doses (MADs) over 14 days of dosing in healthy participants.

Clinical Trial Description

Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12 healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover with an optional fourth dosing period in 10 healthy participants. Participants will be dosed on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36 healthy participants (12 per study cohort). Participants will be dosed on 3 separate occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each treatment period. Parts 2 and 3 are contingent upon successful completion of Part 1. ;

Study Design

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT03464058
Study type	Interventional
Source	Boston Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	March 21, 2018
Completion date	October 10, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05483998` - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants	Phase 1
Recruiting	`NCT02417714` - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Recruiting	`NCT02235012` - Cognitive Biases Under Ketamine	N/A
Completed	`NCT05088343` - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects	Phase 1
Completed	`NCT04418973` - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.	N/A
Not yet recruiting	`NCT06248801` - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets	Phase 1
Terminated	`NCT04068259` - Single Ascending Dose Study of PBI-4547 in Healthy Subjects	Phase 1
Completed	`NCT03279302` - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects	Phase 1
Not yet recruiting	`NCT06233162` - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets	Phase 1
Recruiting	`NCT04159844` - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects	N/A
Completed	`NCT06137911` - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.	Phase 1
Completed	`NCT04849286` - Measurement of HTL0016878 in Cerebrospinal Fluid	Phase 1
Not yet recruiting	`NCT06233227` - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule	Phase 1
Completed	`NCT04096157` - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants	Phase 1
Completed	`NCT01200368` - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants	Phase 3
Recruiting	`NCT05805033` - Peri-Implant Soft Tissue Integration in Humans: Influence of Material	N/A
Completed	`NCT04027803` - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®	Phase 1
Recruiting	`NCT03467880` - Multicenter Study of Impulse Oscillometry in Chinese	N/A
Completed	`NCT02903095` - Single Ascending Dose Study of TD-1439 in Healthy Subjects	Phase 1
Active, not recruiting	`NCT02341508` - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers	Phase 1