Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03464058
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2018-03-07
Brief Title:
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
Sponsor:
Boston Pharmaceuticals
Organization:
Boston Pharmaceuticals
Study Overview
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
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| QCL118174 | OTHER | Quotient Study Number | None |
| 2017-004002-18 | EUDRACT_NUMBER | None | None |