Trial Outcomes & Findings for A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers (NCT NCT03881163)

NCT ID: NCT03881163

Last Updated: 2021-02-24

Results Overview

To evaluate pharmacokinetic parameters of NAC in plasma after single administration of the investigational product.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose
• Results posted on: 2021-02-24

Participant Flow

This study was a single center study conducted in China from 11 November 2019 to 18 January 2020. All participants randomized in the study received single and multiple doses of N-acetylcysteine (NAC).

Participants who met the eligibility criteria at the Screening Visit (Day -14 to Day 1) were assigned to receive NAC.

Participant milestones

Measure	Overall - NAC 600 mg All participants were dosed with NAC once daily (QD) at 08:00 ± 1 hour on Day 1 under fasting conditions, twice daily (BID) at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

Baseline characteristics by cohort

Measure	Overall - NAC 600 mg n=24 Participants All participants were dosed with NAC QD at 08:00 ± 1 hour on Day 1 under fasting conditions, BID at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
Age, Continuous	30.6 years STANDARD_DEVIATION 5.18 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Race/Ethnicity, Customized Chinese	24 Participants n=93 Participants
Region of Enrollment China	24 participants n=93 Participants

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Peak Drug Concentration (Cmax) After Single Dose of NAC	83.30 µg/mL Geometric Coefficient of Variation 30.7

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Time to Achieve Cmax (Tmax) After Single Dose of NAC	0.083 hours Interval 0.08 to 0.25

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Terminal Elimination Rate Constant (Kel) After Single Dose of NAC	0.09723 1/hour Geometric Coefficient of Variation 56.8

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Half-life (t1/2) After Single Dose of NAC	7.129 hour Geometric Coefficient of Variation 56.8

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Area Under the Concentration-time Curve (AUC) After Single Dose of NAC AUC from time zero to the last observed concentration time t [AUC(0-t)]	87.16 h*µg/mL Geometric Coefficient of Variation 17.4
Area Under the Concentration-time Curve (AUC) After Single Dose of NAC AUC extrapolated to infinity [AUC(0-inf)]	93.94 h*µg/mL Geometric Coefficient of Variation 18.0
Area Under the Concentration-time Curve (AUC) After Single Dose of NAC AUC from time zero to 12 hours post-dose [AUC(0-12h)]	81.87 h*µg/mL Geometric Coefficient of Variation 14.0

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Volume of Distribution (Vd) After Single Dose of NAC	65.69 litre Geometric Coefficient of Variation 44.8

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Total Body Clearance (CLt) After Single Dose of NAC	6.387 Liter\hour Geometric Coefficient of Variation 18.0

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(0-4)	62750 μg Geometric Coefficient of Variation 76.4
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(4-8)	16170 μg Geometric Coefficient of Variation 55.2
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(8-12)	3609 μg Geometric Coefficient of Variation 155.0
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(12-24)	1846 μg Geometric Coefficient of Variation 78.0
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(24-32)	1366 μg Geometric Coefficient of Variation 63.9
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(0-8)	84020 μg Geometric Coefficient of Variation 53.4
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(0-12)	89600 μg Geometric Coefficient of Variation 50.5
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(0-24)	92020 μg Geometric Coefficient of Variation 49.4
Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC Ae(0-32)	93490 μg Geometric Coefficient of Variation 48.5

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC Fe(0-4)	0.1046 fraction Geometric Coefficient of Variation 76.4
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC Fe(0-8)	0.1400 fraction Geometric Coefficient of Variation 53.4
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC Fe(0-12)	0.1493 fraction Geometric Coefficient of Variation 50.5
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC Fe(0-24)	0.1534 fraction Geometric Coefficient of Variation 49.4
Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC Fe(0-32)	0.1558 fraction Geometric Coefficient of Variation 48.5

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Renal Clearance (CLr) After Single Dose of NAC	995.2 mL/h Geometric Coefficient of Variation 50.2

PRIMARY outcome

Timeframe: On Day 1 and Day 2-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Percentage of the AUC(0-inf) Obtained by Extrapolation (%AUCextra)	6.967 percentage Geometric Coefficient of Variation 26.8

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

Css_max = maximum NAC plasma concentration at steady-state, Css_min=minimum plasma concentration at steady-state, Css_avg=average NAC plasma concentration at steady-state.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Plasma Concentration at Steady-state After Multiple Doses of NAC Css_max	100.8 µg/mL Geometric Coefficient of Variation 29.1
Plasma Concentration at Steady-state After Multiple Doses of NAC Css_min	1.899 µg/mL Geometric Coefficient of Variation 20.9
Plasma Concentration at Steady-state After Multiple Doses of NAC Css_avg	7.719 µg/mL Geometric Coefficient of Variation 14.1

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Time to Achieve Css_max (tss_max) After Multiple Doses of NAC	0.083 hour Interval 0.07 to 0.13

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

AUCss(0-12h)=AUC at steady-state from the last multiple dose to 12 hours post-dose, AUCss(0-t)=AUC at steady-state from the last multiple dose to the last observed concentration time t.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Area Under the Concentration-time Curve at Steady State After Multiple Doses of NAC AUCss(0-t)	116.6 h*µg/mL Geometric Coefficient of Variation 15.1
Area Under the Concentration-time Curve at Steady State After Multiple Doses of NAC AUCss(0-12h)	92.63 h*µg/mL Geometric Coefficient of Variation 14.1

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Accumulation Ratio After Multiple Doses of NAC	1.132 Ratio Geometric Coefficient of Variation 6.0

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Total Amount of NAC Excreted in Urine From the Last Multiple Dose to 32 h at Steady-state [Aess(0-32)]	68980 μg Geometric Coefficient of Variation 68.1

PRIMARY outcome

Timeframe: On Day 4 and Day 5 -At pre-dose. On Day 6 and Day 7-At pre-dose (0) and 5 (at the end of the infusion), 8, 12, 15, 20, 25, 30, 60 minutes and 2, 4, 6, 8, 10, 12, 24 and 32 hours post-dose.

Population: Pharmacokinetic (PK) set: all enrolled participants who fulfilled the study protocol requirements in terms of investigational medicinal product intake and had evaluable PK data readouts for the planned analyses, with no major deviations that might affect the PK results.

To evaluate pharmacokinetic parameters of NAC in plasma after multiple dose administration of the investigational product.

Degree of fluctuation over one dosing interval at steady-state is calculated as (Css_max - Css_min)/ Css_av*100

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Degree of Fluctuation Over One Dosing Interval at Steady-state (DF%) After Multiple Dose of NAC	1279 percentage Geometric Coefficient of Variation 30.7

SECONDARY outcome

Timeframe: From screening to Final Visit/early termination visit (ETV, Day 8)

Population: Safety set: All participants who received at least one dose of investigational medicinal product.

To collect safety and tolerability data after single and multiple dose administration of the investigational product.

Outcome measures

Measure	Single Dose - NAC 600mg n=24 Participants Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) was administered under fasting conditions.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE	7 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Related to investigational medicinal product	2 Participants

Adverse Events

Overall - NAC 600 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Overall - NAC 600 mg n=24 participants at risk All participants were dosed with NAC once daily (QD) at 08:00 ± 1 hour on Day 1 under fasting conditions, BID at 08:00 ± 1 hour and 20:00 ± 1 hour on Day 4 and Day 5 after one 3-day wash-out, and QD at 08:00 ± 1 hour on Day 6.
Investigations Urine output increased	12.5% 3/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.
Investigations Blood bilirubin increased	4.2% 1/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.
Investigations Blood uric acid increased	4.2% 1/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.
Investigations Weight decreased	4.2% 1/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.
Gastrointestinal disorders Nausea	4.2% 1/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.
Gastrointestinal disorders Retching	4.2% 1/24 • From Screening to Final Visit/Early termination (ETV, Day 8) All AEs/serious adverse events (SAEs), regardless of the relationship to investigational medicinal product, were to be assessed and recorded from the date the informed content form was signed until Final Visit/ETV.

Additional Information

Valentina Vaja

Zambon S.p.A

Phone: +390266524497

Email: Valentina.Vaja@ZambonGroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60