NCT02482324

Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers

A Phase I, Randomized, Open-Labeled Pharmacokinetic Study of ALZT-OP1 in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AZTherapies, Inc. · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled, cross-over design, pharmacokinetic study, to determine the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in healthy volunteers, aged 55-75, and in good general health.

Detailed description

This is an open-labeled, cross-over design, pharmacokinetic study, where 24 subjects will be randomly assigned to receive treatment regimen A-B or B-A on two consecutive days of dosing. Two dosing groups are planned for the study : * Group 1 (n=12) * Group 2 (n=12) Each group will be admitted to the Phase I Unit the evening before dosing and will initiate dosing the next morning for 2-days of consecutive treatment (A-B, or B-A). Both groups will undergo identical study related procedures, except those subjects that consent to CSF collection on Day 1 of dosing. Dose regimen A consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b. Dose regimen B consists of two oral inhaled doses of ALZT-OP1a, not more than 2 minutes apart, via dry powder inhaler + two oral tablet doses of ALZT-OP1b. Plasma Collection, All Subjects (n=24) 1 mL blood samples will be collected at T: 0, 5, 10, 15, 30, 1 hr, 2 hr, 4 hr, and 6 hours, following ALZT-OP1 administration (Days 1 and 2). CSF Collection, Sub-group (n=12) A sub-group of 12 subjects will be consented for CSF collection. 1 mL of CSF will be collected at T: 0, 5 min, 30 min, 2 hr, and 4 hours, following ALZT-OP1 administration (Day 1 only).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ALZT-OP1a	Mast cell stabilizer
DRUG	ALZT-OP1b	anti-inflammatory
DEVICE	Dry Powder Inhaler	The inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-06-26
• Last updated: 2015-07-21

Locations

1 site across 1 country: United States