A Study to Evaluate Pharmacokinetics, Safety and Tolerabi... | NCT03881163

Status Module

Label	Type	Description	Intervention Names
Single dose regime of N-acetylcysteine (NAC)	Experimental	On day 1 at 08:00 ±1 hours, one dose of 600 mg of NAC (300 + 300 mg ampoule) will be administered under fasting conditions.	Drug: N-acetylcysteine (NAC)
Multiple dose regime of N-acetylcysteine (NAC)	Experimental	On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.	Drug: N-acetylcysteine (NAC)

Name	Type	Description	Arm Group Labels	Other Names
N-acetylcysteine (NAC)	Drug	Two ampoules of IMP (300 + 300 mg) corresponding to a total dose of 600 mg of NAC diluted in 10 mL of NaCl 0.9% sterile saline solution, will be administered by a 5-minute i.v. infusion.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Drug Concentration (Cmax) After Single Dose of NAC	To evaluate pharmacokinetic parameters of NAC in plasma after single administration of the investigational product.	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
Time to Achieve Cmax (Tmax) After Single Dose of NAC	To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.	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.
Terminal Elimination Rate Constant (Kel) After Single Dose of NAC	To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.	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.
Half-life (t1/2) After Single Dose of NAC	To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.	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.
Area Under the Concentration-time Curve (AUC) After Single Dose of NAC	To evaluate pharmacokinetic parameters of NAC in plasma after single dose administration of the investigational product.	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.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	To collect safety and tolerability data after single and multiple dose administration of the investigational product.	From screening to Final Visit/early termination visit (ETV, Day 8)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent: signed written informed consent before inclusion in the study
Ethnicity, Sex and Age: Chinese males and females, 18-45 year old inclusive
Weight: body weight ≥50 kg
Body Mass Index: 19-26 kg/m2 inclusive
Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting/supine position
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Nicotine addiction (smoker subjects only): ability to abstain from smoking for the duration of the clinical study
Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 60 calendar days before the screening visit
2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 60 calendar days before the screening visit
3. A male sexual partner who agrees to use a male condom with spermicide
4. A sterile sexual partner

Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. Women of childbearing potential should be willing to adopt abstinence or contraception measures during the study and two weeks post-dose. For all women, pregnancy test result must be negative at screening and day -1.

Exclusion Criteria:

Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness, in particular significant laboratory abnormality indicative of hepatic condition (more than 3 times the upper limit)
Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, urologic, metabolic, neurological or psychiatric diseases, as determined by the investigator, that may interfere with the aim of the study; history of carcinoma in situ and malignant disease; active bacterial or viral infection and fever >38°C within 48 h prior to study treatment administration
Virology: positive result of HIV, hepatitis B (HBV), hepatitis C (HCV) or Treponema pallidum (TP) assays
Surgery: any surgery within 60 calendar days of screening (excluding diagnostic surgery)
Medications: medications, including over the counter (OTC) medications, herbal remedies and traditional Chinese remedies for 2 weeks before the start of the study. Hormonal contraceptives for women will be allowed
Investigative drug studies: participation in the evaluation of any investigational product for 1 month before this study
Blood donation: blood donations for 90 calendar days before this study
Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020] caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes/day)
Abuse drug test: positive urine abuse drug test at screening or day -1
Alcohol test: positive alcohol breath test at day -1
Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; consumption of alcohol, grapefruit, products containing grapefruit, or beverages containing xanthines (coffee, tea, soda, coffee with milk, energy drinks) within 48 hours prior to the enrolment
Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women
Vaccination within 4 weeks of study treatment
Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrolment.

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine		Shanghai	No.197 Ruijin Er Road		China

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 3, 2019	Dec 24, 2020

ID	Title	Description
BG000	Overall - NAC 600 mg	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.

Units	Counts
Participants	BG00024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Peak Drug Concentration (Cmax) After Single Dose of NAC

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

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

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

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG00024

Title

Denominators

Categories

Title	Measurements
	OG00083.30± 30.7

Primary

Time to Achieve Cmax (Tmax) After Single Dose of NAC

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

Posted

Median

Full Range

hours

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Terminal Elimination Rate Constant (Kel) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

1/hour

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Half-life (t1/2) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

hour

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Area Under the Concentration-time Curve (AUC) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

h*µg/mL

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Volume of Distribution (Vd) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

litre

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Total Body Clearance (CLt) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter\hour

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Total Amount of NAC Excreted in Urine [Ae(0-t)] After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

μg

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Total Fraction of NAC Dose Excreted in Urine [Fe(0-t)] After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

fraction

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Renal Clearance (CLr) After Single Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/h

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Percentage of the AUC(0-inf) Obtained by Extrapolation (%AUCextra)

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

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage

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.

ID	Title	Description
OG000	Single Dose - NAC 600mg	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.

Units	Counts
Participants	OG000

Primary

Plasma Concentration at Steady-state After Multiple Doses of NAC

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants	OG000

Primary

Time to Achieve Css_max (tss_max) After Multiple Doses of NAC

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

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.

Posted

Median

Full Range

hour

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants	OG000

Primary

Area Under the Concentration-time Curve at Steady State After Multiple Doses of NAC

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*µg/mL

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants	OG000

Primary

Accumulation Ratio After Multiple Doses of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants	OG000

Primary

Total Amount of NAC Excreted in Urine From the Last Multiple Dose to 32 h at Steady-state [Aess(0-32)]

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

Posted

Geometric Mean

Geometric Coefficient of Variation

μg

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants	OG000

Primary

Degree of Fluctuation Over One Dosing Interval at Steady-state (DF%) After Multiple Dose of NAC

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

Posted

Geometric Mean

Geometric Coefficient of Variation

percentage

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.

ID	Title	Description
OG000	Multiple Dose - NAC 600mg	Participants who met the eligibility criteria at the Screening Visit were assigned to receive NAC. On days 4 and 5 at 08:00 ±1 hours and 20:00 ±1 hours and at 08:00 ±1 on day 6, 5 doses of 600 mg of NAC (300 + 300 mg ampoule) will be administered.

Units	Counts
Participants

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	NAC 600 mg	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.

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urine output increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0003 affected24 at risk
Blood bilirubin increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0001 affected24 at risk
Blood uric acid increased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0001 affected24 at risk
Weight decreased	Investigations	MedDRA 22.0	Non-systematic Assessment	EG0001 affected24 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 affected24 at risk
Retching	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 affected24 at risk

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins