Trial Outcomes & Findings for Safety and Efficacy Study of DAV132 in Healthy Volunteers (NCT NCT02176005)

NCT ID: NCT02176005

Last Updated: 2020-02-28

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

44 participants

Primary outcome timeframe

D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16

Results posted on

2020-02-28

Participant Flow

Healthy volunteers were recruited from March 20th, 2014 (date of first enrolment) and October 17th, 2014 (date of last completed)

Participant milestones

Participant milestones
Measure	Moxifloxacin Moxifloxacin (oral tablets, 400mg x1/day for 5 days) used alone	DAV132 + Moxifloxacin DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)	DAV132 DAV132 (7.5g x3/day taken orally for 7 days) used alone	Negative Control Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)
Overall Study STARTED	14	14	8	8
Overall Study COMPLETED	14	14	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of DAV132 in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moxifloxacin n=14 Participants Moxifloxacin (400mg x1/day taken orally for 5 days) used alone	DAV132 + Moxifloxacin n=14 Participants DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)	DAV132 n=8 Participants DAV132 (7.5g x3/day taken orally for 7 days) used alone	Negative Control n=8 Participants Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)	Total n=44 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 10.4 • n=5 Participants	38.6 years STANDARD_DEVIATION 12.1 • n=7 Participants	27.9 years STANDARD_DEVIATION 9.1 • n=5 Participants	36.7 years STANDARD_DEVIATION 11.8 • n=4 Participants	35.3 years STANDARD_DEVIATION 11.3 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment France	14 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	44 Participants n=21 Participants
Body Mass Index (BMI) at screening visit	24.1 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants	24.9 kg/m^2 STANDARD_DEVIATION 3.2 • n=7 Participants	23.6 kg/m^2 STANDARD_DEVIATION 3.2 • n=5 Participants	23.3 kg/m^2 STANDARD_DEVIATION 2.0 • n=4 Participants	24.1 kg/m^2 STANDARD_DEVIATION 3.0 • n=21 Participants

PRIMARY outcome

Timeframe: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)	758.4 μg/g.day Standard Deviation 359.3	8.28 μg/g.day Standard Deviation 7.21	—	—

SECONDARY outcome

Timeframe: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)	758.7 μg/g.day Standard Deviation 359.5	8.74 μg/g.day Standard Deviation 7.73	—	—

SECONDARY outcome

Timeframe: D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1	42.1 µg/mL.h Standard Deviation 7.01	41.9 µg/mL.h Standard Deviation 9.57	—	—

SECONDARY outcome

Timeframe: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5	57.6 µg/mL.h Standard Deviation 13.83	50.5 µg/mL.h Standard Deviation 10.91	—	—

SECONDARY outcome

Timeframe: D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1	4.02 µg/mL Standard Deviation 1.33	4.63 µg/mL Standard Deviation 0.97	—	—

SECONDARY outcome

Timeframe: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5	4.89 µg/mL Standard Deviation 1.21	4.60 µg/mL Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: From randomization to 37 days after the beginning of treatment

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 n=8 Participants DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control n=8 Participants Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product	1 events related to study product	0 events related to study product	0 events related to study product	0 events related to study product

SECONDARY outcome

Timeframe: From randomization to 37 days after the beginning of treatment

Outcome measures

Outcome measures
Measure	Moxifloxacin n=14 Participants Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	Moxifloxacin + DAV132 n=14 Participants Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone Moxifloxacin: Moxifloxacin is used alone or associated to DAV132	DAV132 n=8 Participants DAV132 oral, 7.5g x3/day for 7 days DAV132: DAV132 is associated to moxifloxacin or it is evaluated alone	Negative Control n=8 Participants Negative control: 7.5g x3/day for 7 days Negative Control: Moxifloxacin is used alone
Percentage of Subjects With Adverse Events Related to Study Product	7.14 % of subjects with at last 1 related AE	0 % of subjects with at last 1 related AE	0 % of subjects with at last 1 related AE	0 % of subjects with at last 1 related AE

Adverse Events

Moxifloxacin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Moxifloxacin + DAV132

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

DAV132

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Negative Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Annie Ducher, Chief Medical Officer

Da Volterra

Phone: +33 1 58 39 32 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Moxifloxacin n=14 participants at risk Moxifloxacin (400mg x1/day taken orally for 5 days) used alone	Moxifloxacin + DAV132 n=14 participants at risk DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days)	DAV132 n=8 participants at risk DAV132 (7.5g x3/day taken orally for 7 days) used alone	Negative Control n=8 participants at risk Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days)
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	12.5% 1/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Gastrointestinal disorders Flatulence	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	14.3% 2/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Gastrointestinal disorders Nausea	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
General disorders Asthenia	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Investigations Intestinal transit time abnormal	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	12.5% 1/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Nervous system disorders Formication	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Nervous system disorders Headache	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	28.6% 4/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	12.5% 1/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Nervous system disorders Syncope	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Psychiatric disorders Anxiety	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Renal and urinary disorders Pollakiuria	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	12.5% 1/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Reproductive system and breast disorders Vulvovaginal mycotic infection	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	7.1% 1/14 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)	0.00% 0/8 • Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)