Trial Outcomes & Findings for A Single Dose-escalation Study of Cytisine in Adult Smokers (NCT NCT03848208)
NCT ID: NCT03848208
Last Updated: 2020-09-17
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
From first dose of study drug through Day 6
Results posted on
2020-09-17
Participant Flow
Participants were enrolled in a single center in Portugal.
Participants were randomly assigned to receive a single oral dose of cytisine or placebo in a 3:1 ratio (6 cytisine:2 placebo) for each dose cohort. Seventy-four (74) participants were randomized; 2 were withdrawn from the study by physician decision before dosing (1 due to high blood pressure and 1 due to noncompliance with protocol restrictions).
Participant milestones
| Measure |
Placebo
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Dose-escalation Study of Cytisine in Adult Smokers
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
n=6 Participants
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
n=6 Participants
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
n=6 Participants
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
n=6 Participants
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
n=6 Participants
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
n=6 Participants
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
n=6 Participants
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
n=6 Participants
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
n=6 Participants
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 7.5 • n=21 Participants
|
37.8 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
30.3 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
30.0 years
STANDARD_DEVIATION 5.5 • n=24 Participants
|
30.3 years
STANDARD_DEVIATION 4.6 • n=42 Participants
|
29.7 years
STANDARD_DEVIATION 8.9 • n=42 Participants
|
33.5 years
STANDARD_DEVIATION 9.2 • n=42 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through Day 6Population: Safety Set: all participants who received study drug.
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
n=6 Participants
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
n=6 Participants
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
n=6 Participants
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
n=6 Participants
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
n=6 Participants
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
n=6 Participants
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
n=6 Participants
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
n=6 Participants
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
n=6 Participants
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation
Any TEAE
|
5 participants
|
2 participants
|
1 participants
|
4 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation
Serious TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation
TEAE Leading to Study Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dosePopulation: Pharmacokinetic Analysis Set: all participants who received a dose of cytisine and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
n=6 Participants
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
n=6 Participants
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
n=6 Participants
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
n=6 Participants
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
n=6 Participants
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
n=6 Participants
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
n=6 Participants
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
n=6 Participants
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
|
71.05 ng/mL
Interval 56.07 to 86.03
|
93.62 ng/mL
Interval 79.44 to 107.79
|
94.27 ng/mL
Interval 74.87 to 113.66
|
126.45 ng/mL
Interval 100.82 to 152.07
|
134.94 ng/mL
Interval 107.0 to 162.88
|
150.08 ng/mL
Interval 114.12 to 186.04
|
171.44 ng/mL
Interval 149.31 to 193.57
|
151.05 ng/mL
Interval 122.01 to 180.08
|
166.65 ng/mL
Interval 120.95 to 212.34
|
—
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dosePopulation: Pharmacokinetic Analysis Set: all participants who received a dose of cytisine and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
n=6 Participants
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
n=6 Participants
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
n=6 Participants
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
n=6 Participants
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
n=6 Participants
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
n=6 Participants
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
n=6 Participants
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
n=6 Participants
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time to Occurrence of Cmax (Tmax)
|
0.83 hours
Interval 0.5 to 2.0
|
1.38 hours
Interval 0.83 to 2.5
|
1.88 hours
Interval 1.25 to 2.5
|
1.88 hours
Interval 0.5 to 2.5
|
2.00 hours
Interval 1.5 to 3.0
|
1.89 hours
Interval 1.25 to 3.0
|
2.50 hours
Interval 0.83 to 3.0
|
2.75 hours
Interval 1.75 to 3.0
|
2.50 hours
Interval 1.0 to 3.0
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cytisine 6 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cytisine 9 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cytisine 12 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cytisine 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cytisine 18 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cytisine 21 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cytisine 24 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cytisine 27 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cytisine 30 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo to match Cytisine 6-30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 6 mg
n=6 participants at risk
Cytisine 6 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 9 mg
n=6 participants at risk
Cytisine 9 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 12 mg
n=6 participants at risk
Cytisine 12 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 15 mg
n=6 participants at risk
Cytisine 15 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 18 mg
n=6 participants at risk
Cytisine 18 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 21 mg
n=6 participants at risk
Cytisine 21 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 24 mg
n=6 participants at risk
Cytisine 24 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 27 mg
n=6 participants at risk
Cytisine 27 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
Cytisine 30 mg
n=6 participants at risk
Cytisine 30 mg administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
33.3%
2/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
33.3%
2/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
33.3%
2/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
33.3%
2/6 • From first dose of study drug through Day 6
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
33.3%
2/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • From first dose of study drug through Day 6
|
16.7%
1/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
0.00%
0/6 • From first dose of study drug through Day 6
|
Additional Information
Daniel Cain, Vice President, Clinical Research
Achieve Life Sciences
Phone: 425.686.1546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER