NCT04683926

A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects

A Phase 1 Randomized Single Oral Dose Cross-Over Study Investigating Desmetramadol Dose Proportionality And Food Effect In Normal Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.

Detailed description

An open-label, randomized, balanced, single-dose, four-treatment, four-period, four-sequence (using a Williams' square design) cross-over study with each dose separated by \>3 days. There are 4 sequences (Sequence 1, Sequence 2, Sequence 3, and Sequence 4), and 4 Periods (Period I, Period II, Period III, and Period IV). Sequence 1 order is 30 mg dose with food (Period I); 30 mg dose fasted (Period II), 10 mg dose fasted (Period III), and 20 mg dose fasted (Period IV). Sequence 2 order is 10 mg dose fasted (Period I); 30 mg dose with food (Period II), 20 mg dose fasted (Period III), and 30 mg dose fasted (Period IV). Sequence 3 order is 20 mg dose fasted (Period I); 10 mg dose fasted (Period II), 30 mg dose fasted (Period III), and 30 mg dose with food (Period IV). Sequence 4 order is 30 mg dose fasted (Period I); 20 mg dose fasted (Period II), 30 mg dose with food (Period III), and 10 mg dose fasted (Period IV). To account for potential dropouts, up to 32 eligible subjects will be randomized to obtain a target sample of 24 subjects with PK responses at each of the four treatment periods (based on our completed phase 1 study in 43 subjects, dropouts are unlikely (\~5%); see Section 1.2.2). Before each oral dose, subjects will be fasted overnight for at least 10 hours. Treatment sequences will include the following four unblinded single-dose oral treatments: 1) desmetramadol 1 x 10 mg tablet; 2) desmetramadol 2 x 10 mg tablets; 3) desmetramadol 3 x 10 mg tablets; and 4) desmetramadol 3 x 10 mg tablets following a high-fat, high-calorie breakfast served approximately 30 minutes before dosing and entirely consumed within 20 minutes. All subjects will fast for an additional four hours after desmetramadol administration. The fed treatment should be administered the desmetramadol dose approximately 30 minutes after the start of the meal. Desmetramadol will be administered with approximately 240 ml of water. No water is allowed one hour before and one hour after each desmetramadol administration. This will be an inpatient study. Subjects will be admitted to the clinical pharmacology unit on Study Day -1, and administered a single oral dose treatment on Study Day 1, Study Day 4, Study Day 7 and Study Day 10. After completing study procedures on Day 11 the subject will be discharged from the facility. Blood specimens for plasma preparation and PK analysis will be collected at the following times: pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, and 32 h.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Desmetramadol	Analgesic

Timeline

• Start date: 2021-01-08
• Primary completion: 2021-01-18
• Completion: 2021-01-18
• First posted: 2020-12-24
• Last updated: 2023-04-04
• Results posted: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study