Trial Outcomes & Findings for F901318 Single Ascending Dose Study in Healthy Male Volunteers (NCT NCT02142153)

NCT ID: NCT02142153

Last Updated: 2015-09-07

Results Overview

Adverse events will be collected from the time of screening until the final study visit

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Single dose

Results posted on

2015-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	F901318 0.25 mg/kg Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	0.25 mg/kg Placebo Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 0.75 mg/kg Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 0.75 mg/kg Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 1.5 mg/kg Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 1.5 mg/kg Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 3 mg/kg Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 3 mg/kg Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 4 mg/kg Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 4 mg/kg Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
Overall Study STARTED	6	2	6	2	6	2	6	2	6	2
Overall Study COMPLETED	6	2	6	2	6	2	6	2	6	2
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

F901318 Single Ascending Dose Study in Healthy Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	F901318 0.25 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	0.25 mg/kg Placebo n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 0.75 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 0.75 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 1.5 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 1.5 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 3 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 3 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 4 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 4 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	Total n=40 Participants Total of all reporting groups
Age, Categorical >=65 years	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	40 Participants n=42 Participants
Age, Categorical <=18 years	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	40 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	40 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants	2 participants n=8 Participants	6 participants n=8 Participants	2 participants n=24 Participants	6 participants n=42 Participants	2 participants n=42 Participants	40 participants n=42 Participants

PRIMARY outcome

Timeframe: Single dose

Population: Full analytical set

Adverse events will be collected from the time of screening until the final study visit

Outcome measures

Outcome measures
Measure	F901318 0.25 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	0.25 mg/kg Placebo n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 0.75 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 0.75 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 1.5 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 1.5 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 3 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 3 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 4 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 4 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
Number of Subjects With Adverse Events	1 participants	1 participants	1 participants	1 participants	1 participants	0 participants	1 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Single dose

Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit

Outcome measures

Outcome measures
Measure	F901318 0.25 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	0.25 mg/kg Placebo n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 0.75 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 0.75 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 1.5 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 1.5 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 3 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 3 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities	F901318 4 mg/kg n=6 Participants Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile	Placebo 4 mg/kg n=2 Participants Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities	6 participants	2 participants	6 participants	2 participants	6 participants	2 participants	6 participants	2 participants	6 participants	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Single dose

Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).