Trial Outcomes & Findings for A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects (NCT NCT01650324)

Results Overview

There were 4 mild adverse events observed during the course of study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.

Results posted on

2014-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg Participants received a single oral dose of DBPR108 600 mg
Overall Study STARTED	8	6	6	6	6
Overall Study COMPLETED	8	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg n=6 Participants Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg n=6 Participants Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg n=6 Participants Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg n=6 Participants Participants received a single oral dose of DBPR108 600 mg	Total n=32 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 8 • n=5 Participants	26 years STANDARD_DEVIATION 2 • n=7 Participants	24 years STANDARD_DEVIATION 2 • n=5 Participants	27 years STANDARD_DEVIATION 5 • n=4 Participants	26 years STANDARD_DEVIATION 6 • n=21 Participants	27 years STANDARD_DEVIATION 6 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	32 Participants n=10 Participants

PRIMARY outcome

Timeframe: Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.

Population: All enrolled participants.

There were 4 mild adverse events observed during the course of study.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg n=6 Participants Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg n=6 Participants Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg n=6 Participants Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg n=6 Participants Participants received a single oral dose of DBPR108 600 mg
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	0 participants	0 participants	0 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose

Population: All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.

Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg n=6 Participants Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg n=6 Participants Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg n=6 Participants Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg Participants received a single oral dose of DBPR108 600 mg
Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)	236 ng*h/mL Standard Deviation 66.9	1310 ng*h/mL Standard Deviation 290	3910 ng*h/mL Standard Deviation 1200	10500 ng*h/mL Standard Deviation 2400	—

SECONDARY outcome

Timeframe: predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose

Population: All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.

Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg n=6 Participants Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg n=6 Participants Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg n=6 Participants Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg Participants received a single oral dose of DBPR108 600 mg
Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax)	47.2 ng/mL Standard Deviation 23.8	187 ng/mL Standard Deviation 33.3	571 ng/mL Standard Deviation 158	1370 ng/mL Standard Deviation 235	—

SECONDARY outcome

Timeframe: predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose

Population: All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.

Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg	DBPR108 25 mg n=6 Participants Participants received a single oral dose of DBPR108 25 mg	DBPR108 100 mg n=6 Participants Participants received a single oral dose of DBPR108 100 mg	DBPR108 300 mg n=6 Participants Participants received a single oral dose of DBPR108 300 mg	DBPR108 600 mg Participants received a single oral dose of DBPR108 600 mg
Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax)	1.50 hrs Interval 1.5 to 4.0	4.02 hrs Interval 1.5 to 4.03	4.00 hrs Interval 1.0 to 6.0	4.01 hrs Interval 2.0 to 6.0	—

SECONDARY outcome

Timeframe: predose (0 hr) and 48 hrs post dose

Population: All enrolled participants.

Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.