Trial Outcomes & Findings for Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension (NCT NCT06585163)
NCT ID: NCT06585163
Last Updated: 2026-08-05
Results Overview
Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and/or pulse oximetry
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Day 1 to Day 5
Results posted on
2026-08-05
Participant Flow
Recruitment of 36 healthy male and female volunteers between Aug 18, 2025 and Sept 8, 2025 inclusive.
23 subjects were screened on Aug 18, 2025. 12 subjects were screened on Aug 20, 2025. 1 subject was screened on Sept 8, 2025. 8 subjects were enrolled on Aug 18, 2025.
Participant milestones
| Measure |
Sequence A - Hydrocodone Alone Followed by Combined (Hydrocodone + Doxapram)
Subjects randomized to Sequence A will first receive a single oral administration of hydrocodone bitartrate alone on Study Day-2 and then receive a combination of hydrocodone bitartrate and doxapram hydrocholoride on study Day-4 (after a 48 hour wash-out).
|
Sequence B - Combined (Hydrocodone + Doxapram) Followed by Hydrocodone Alone
Subjects randomized to Sequence B will first receive a single combined administration of hydrocodone bitartrate and doxapram hydrocholoride on Study Day-2 and then receive hydrocodone alone on study Day-4 (after a 48 hour wash-out).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
Baseline characteristics by cohort
| Measure |
Sequence A - Hydrocodone Alone Followed by Combined (Hydrocodone + Doxapram)
n=4 Participants
Subjects randomized to Sequence A will first receive a single oral administration of hydrocodone bitartrate alone on Study Day-2 and then receive a combination of hydrocodone bitartrate and doxapram hydrocholoride on study Day-4 (after a 48 hour wash-out).
|
Sequence B - Combined (Hydrocodone + Doxapram) Followed by Hydrocodone Alone
n=4 Participants
Subjects randomized to Sequence B will first receive a single combined administration of hydrocodone bitartrate and doxapram hydrocholoride on Study Day-2 and then receive hydrocodone alone on study Day-4 (after a 48 hour wash-out).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 5.92 • n=20 Participants
|
36.5 years
STANDARD_DEVIATION 6.24 • n=20 Participants
|
37.0 years
STANDARD_DEVIATION 5.66 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Ethnicity / Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Ethnicity / Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and/or pulse oximetry
Outcome measures
| Measure |
Hydrocodone Bitartrate Alone
n=8 Participants
Hydrocodone Bitartrate Alone
|
Hydrocodone Bitartrate + Doxapram Hydrochloride
n=8 Participants
Hydrocodone Bitartrate + Doxapram Hydrochloride
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2 and Day 4Maximal plasma concentrations for hydrocodone
Outcome measures
| Measure |
Hydrocodone Bitartrate Alone
n=8 Participants
Hydrocodone Bitartrate Alone
|
Hydrocodone Bitartrate + Doxapram Hydrochloride
n=8 Participants
Hydrocodone Bitartrate + Doxapram Hydrochloride
|
|---|---|---|
|
Plasma PK Parameters (Cmax)
|
22.0 ng/mL
Standard Deviation 5.4
|
19.3 ng/mL
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day 2 and Day 4Plasma area under the curve from 0 to 24h for hydrocodone
Outcome measures
| Measure |
Hydrocodone Bitartrate Alone
n=8 Participants
Hydrocodone Bitartrate Alone
|
Hydrocodone Bitartrate + Doxapram Hydrochloride
n=8 Participants
Hydrocodone Bitartrate + Doxapram Hydrochloride
|
|---|---|---|
|
Plasma PK Parameter (AUC0-24h)
|
144 ng*h/mL
Standard Error 27
|
146 ng*h/mL
Standard Error 22
|
SECONDARY outcome
Timeframe: Day 2 and Day 4Time to maximal plasma concentrations for hydrocodone
Outcome measures
| Measure |
Hydrocodone Bitartrate Alone
n=8 Participants
Hydrocodone Bitartrate Alone
|
Hydrocodone Bitartrate + Doxapram Hydrochloride
n=8 Participants
Hydrocodone Bitartrate + Doxapram Hydrochloride
|
|---|---|---|
|
Plasma PK Parameter (Tmax)
|
1.5 h
Interval 1.0 to 3.0
|
1.7 h
Interval 1.0 to 4.0
|
Adverse Events
Hydrocodone Bitartrate Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrocodone Bitartrate + Doxapram Hydrochloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter J Rix, Chief Scientific Officer
Quivive Pharma, Inc.
Phone: 8583362334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60