LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

• Sponsor: Terns, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04328077
• Collaborator: (none)
• Enrollment: 101
• Locations: 31
• Arms: 4
• Actual Duration (Months): 11
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: TERN-101; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
• Actual Study Start Date: Jun 18, 2020
• Actual Primary Completion Date: May 19, 2021
• Actual Study Completion Date: May 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TERN-101 dose level 1 Orally administered.	Drug: TERN-101; Investigational drug
Experimental: TERN-101 dose level 2 Orally administered.	Drug: TERN-101; Investigational drug
Experimental: TERN-101 dose level 3 Orally administered.	Drug: TERN-101; Investigational drug
Placebo Comparator: Placebo Orally administered.	Other: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events for TERN-101 Versus Placebo [16 weeks]

Secondary Outcome Measures

1. Percent Change From Baseline in ALT Outcome Measure [12 weeks]

2. Plasma Concentration of TERN-101 - AUC 0-24 [12 weeks (0-24 hours post dose)]

   Area under the curve

3. Plasma Concentration of TERN-101 - Cmax [12 Weeks (0-72 hours post dose)]

   Maximum observed concentration

4. Plasma Concentration of TERN-101 - Tmax [12 Weeks (0-72 hours post dose)]

   Time to reach maximum measured plasma concentration

5. Plasma Concentration of TERN-101 - t1/2 [12 Weeks (0-72 hours post dose)]

   Determination of half-life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, 18 to 75 years of age

• Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2

• Presumed NASH based on clinical characteristics or prior liver biopsy

• ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women

• MRI PDFF liver fat content ≥ 10 %

• Written informed consent

Exclusion Criteria:

• History or clinical evidence of chronic liver diseases other than NAFLD

• History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment

• History of liver transplant, or current placement on a liver transplant list

• Total bilirubin > 1.2 mg/dL

• Albumin < 3.5 g/dL

• INR > 1.1

• AST or ALT > 5 x ULN

• ALP > 156 IU/L

• Platelet count < 150,000 /mm3

• eGFR < 60 mL/min/1.73m2

• Weight loss > 5% within past 3 months prior to Screening

• Uncontrolled diabetes

• Uncontrolled hyperlipidemia

• Active COVID-19 infection

• Other protocol-defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Terns Clinical Study Site 1017	Chandler	Arizona	United States	85224
2	Terns Clinical Study Site 1018	Tucson	Arizona	United States	85712
3	Terns Clinical Study Site 1024	Tucson	Arizona	United States	85712
4	Terns Clinical Study Site 1004	Coronado	California	United States	92117
5	Terns Clinical Study Site 1035	Fresno	California	United States	93720
6	Terns Clinical Study Site 1013	La Jolla	California	United States	92037
7	Terns Clinical Study Site 1016	Los Angeles	California	United States	90036
8	Terns Clinical Study Site 1008	Montclair	California	United States	91763
9	Terns Clinical Study Site 1001	Panorama City	California	United States	91402
10	Terns Clinical Study Site 1012	Gainesville	Florida	United States	32610
11	Terns Clinical Study Site 1007	Hialeah	Florida	United States	33013
12	Terns Clinical Study Site 1028	Hialeah	Florida	United States	33014
13	Terns Clinical Study Site 1009	Miami	Florida	United States	33166
14	Terns Clinical Study Site 1033	Orlando	Florida	United States	32806
15	Terns Clinical Study Site 1032	Indianapolis	Indiana	United States	46202
16	Terns Clinical Study Site 1010	Bastrop	Louisiana	United States	71220
17	Terns Clinical Study Site 1037	New Orleans	Louisiana	United States	70121
18	Terns Clinical Study Site 1023	Shreveport	Louisiana	United States	71105
19	Terns Clinical Study Site 1002	Baltimore	Maryland	United States	21202
20	Terns Clinical Study Site 1011	Boston	Massachusetts	United States	02118
21	Terns Clinical Study Site 1038	Florham Park	New Jersey	United States	07932
22	Terns Clinical Study Site 1027	Durham	North Carolina	United States	27710
23	Terns Clinical Study Site 1014	Hermitage	Tennessee	United States	37076
24	Terns Clinical Study Site 1005	Arlington	Texas	United States	76012
25	Terns Clinical Study Site 1025	Georgetown	Texas	United States	78628
26	Terns Clinical Study Site 1021	Houston	Texas	United States	77030
27	Terns Clinical Study Site 1029	Houston	Texas	United States	77030
28	Terns Clinical Study Site 1006	San Antonio	Texas	United States	78215
29	Terns Clinical Study Site 1003	San Antonio	Texas	United States	78229
30	Terns Clinical Study Site 1019	San Antonio	Texas	United States	78229
31	Terns Clinical Study Site 1022	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Terns, Inc.

Investigators

• Study Director: [e-mail], Terns, Inc.

Study Documents (Full-Text)

• Study Protocol - May 22, 2020
• Statistical Analysis Plan - May 19, 2021

More Information

Publications

None provided.

• Responsible Party: Terns, Inc.
• ClinicalTrials.gov Identifier: NCT04328077
• Other Study ID Numbers: TERN101-2001
• First Posted: Mar 31, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Terns, Inc.: Farnesoid X receptor; NASH; Nonalcoholic Steatohepatitis; NAFLD; Nonalcoholic Fatty Liver Disease; FXR
• Additional relevant MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

Participant Flow

Arm/Group Title	Placebo	TERN-101 5mg	TERN-101 10mg	TERN-101 15mg
Arm/Group Description	Placebo Comparator: Placebo: Orally administered	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Period Title: Overall Study
STARTED	26	25	26	24
COMPLETED	26	23	25	21
NOT COMPLETED	0	2	1	3

Baseline Characteristics

Arm/Group Title	Placebo	TERN-101 5mg	TERN-101 10mg	TERN-101 15mg	Total
Arm/Group Description	Placebo Comparator: Placebo: Orally administered	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered	Total of all reporting groups
Overall Participants	26	25	26	23	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	24 96%	23 88.5%	21 91.3%	94 94%
>=65 years	0 0%	1 4%	3 11.5%	2 8.7%	6 6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.4 (11.00)	48.0 (12.32)	52.5 (13.64)	51.6 (9.49)	50.6 (11.71)
Sex: Female, Male (Count of Participants)
Female	16 61.5%	15 60%	17 65.4%	17 73.9%	65 65%
Male	10 38.5%	10 40%	9 34.6%	6 26.1%	35 35%
Race/Ethnicity, Customized (Count of Participants)
White	21 80.8%	23 92%	21 80.8%	21 91.3%	86 86%
Black or African American	2 7.7%	1 4%	2 7.7%	0 0%	5 5%
Asian	1 3.8%	1 4%	1 3.8%	0 0%	3 3%
American Indian or Alaskan Native	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Other	2 7.7%	0 0%	2 7.7%	2 8.7%	6 6%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	20 76.9%	17 68%	16 61.5%	17 73.9%	70 70%
Not Hispanic or Latino	6 23.1%	8 32%	9 34.6%	4 17.4%	27 27%
Not Reported	0 0%	0 0%	0 0%	1 4.3%	1 1%
Unknown	0 0%	0 0%	1 3.8%	1 4.3%	2 2%
Region of Enrollment (Count of Participants)
United States	26 100%	25 100%	26 100%	23 100%	100 100%
ALT (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]	55.51 (23.639)	56.25 (16.266)	60.84 (29.075)	55.79 (26.447)	57.15 (24.064)
Diabetes Mellitus Status (Count of Participants)
Absent	15 57.7%	14 56%	10 38.5%	15 65.2%	54 54%
Present	11 42.3%	11 44%	16 61.5%	8 34.8%	46 46%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events for TERN-101 Versus Placebo
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Safety Population: All patients who received at least 1 dose of study drug

Arm/Group Title	Placebo	TERN-101 5 mg	TERN-101 10 mg	TERN-101 15 mg
Arm/Group Description	Placebo Comparator: Placebo: Orally administered	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	26	25	26	23
Count of Participants [Participants]	10 38.5%	13 52%	14 53.8%	15 65.2%

2. Secondary Outcome

Title	Percent Change From Baseline in ALT Outcome Measure
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Efficacy Population: All randomized patients who received at least 1 dose of study drug

Arm/Group Title	Placebo	TERN-101 5 mg	TERN-101 10 mg	TERN-101 15 mg
Arm/Group Description	Placebo Comparator: Placebo: Orally administered	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	25	24	25	21
Least Squares Mean (Standard Error) [percentage of change from baseline]	-5.33 (6.606)	-2.63 (6.743)	-17.99 (6.646)	-13.22 (7.246)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, TERN-101 5 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7755
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.70
	Confidence Interval	(2-Sided) 95%; -16.1 to 21.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.440
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, TERN-101 10 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1798
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.66
	Confidence Interval	(2-Sided) 95%; -31.3 to 5.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.369
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, TERN-101 15 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4229
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.90
	Confidence Interval	(2-Sided) 95%; -27.4 to 11.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 9.807
	Estimation Comments

3. Secondary Outcome

Title	Plasma Concentration of TERN-101 - AUC 0-24
Description	Area under the curve
Time Frame	12 weeks (0-24 hours post dose)

Outcome Measure Data

Analysis Population Description

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of AUC required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; Negative slope for log regression fit.

Arm/Group Title	TERN-101 5mg	TERN-101 10mg	TERN-101 15mg
Arm/Group Description	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	4	4	5
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	1380 (96.7)	1470 (29.7)	2510 (13.3)

4. Secondary Outcome

Title	Plasma Concentration of TERN-101 - Cmax
Description	Maximum observed concentration
Time Frame	12 Weeks (0-72 hours post dose)

Outcome Measure Data

Analysis Population Description

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

Arm/Group Title	TERN-101 5 mg	TERN-101 10 mg	TERN-101 15 mg
Arm/Group Description	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	116 (45.0)	155 (158.8)	389 (19.0)

5. Secondary Outcome

Title	Plasma Concentration of TERN-101 - Tmax
Description	Time to reach maximum measured plasma concentration
Time Frame	12 Weeks (0-72 hours post dose)

Outcome Measure Data

Analysis Population Description

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101.

Arm/Group Title	TERN-101 5 mg	TERN-101 10 mg	TERN-101 15 mg
Arm/Group Description	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	6	6	6
Median (Full Range) [hour]	1	1	0.5

6. Secondary Outcome

Title	Plasma Concentration of TERN-101 - t1/2
Description	Determination of half-life
Time Frame	12 Weeks (0-72 hours post dose)

Outcome Measure Data

Analysis Population Description

All randomized patients in the PK/PD substudy who received at least 1 dose of TERN-101. The minimum requirement for the calculation of t1/2 required: A minimum of 3 measurable concentration-time-points during the log-linear portion of the terminal elimination phase (after Tmax), excluding Cmax; r²adj ≥ 0.80 for the regression of the log-concentration time data during the terminal elimination phase; and negative slope for log regression fit.

Arm/Group Title	TERN-101 5 mg	TERN-101 10 mg	TERN-101 15 mg
Arm/Group Description	Experimental: TERN-101 dose level 1: Orally administered	Experimental: TERN-101 dose level 2: Orally administered	Experimental: TERN-101 dose level 3: Orally administered
Measure Participants	4	4	5
Median (Full Range) [hour]	14.6	6.75	6

Adverse Events

Time Frame	16 Weeks
Arm/Group Title	Placebo		TERN-101 5mg		TERN-101 10mg		TERN-101 15mg
Arm/Group Description	Placebo Comparator: Placebo: Orally administered		Experimental: TERN-101 dose level 1: Orally administered		Experimental: TERN-101 dose level 2: Orally administered		Experimental: TERN-101 dose level 3: Orally administered
All Cause Mortality
	Placebo		TERN-101 5mg		TERN-101 10mg		TERN-101 15mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/26 (0%)		0/23 (0%)
Serious Adverse Events
	Placebo		TERN-101 5mg		TERN-101 10mg		TERN-101 15mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/26 (3.8%)		0/25 (0%)		0/26 (0%)		1/23 (4.3%)
Infections and infestations
COVID-19 pneumonia	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Urinary tract infection	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Other (Not Including Serious) Adverse Events
	Placebo		TERN-101 5mg		TERN-101 10mg		TERN-101 15mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/26 (38.5%)		13/25 (52%)		14/26 (53.8%)		15/23 (65.2%)
Eye disorders
Vision blurred	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Gastrointestinal disorders
Constipation	2/26 (7.7%)	2	1/25 (4%)	1	1/26 (3.8%)	1	1/23 (4.3%)	1
Diarrhoea	2/26 (7.7%)	2	0/25 (0%)	0	0/26 (0%)	0	2/23 (8.7%)	2
Nausea	1/26 (3.8%)	1	1/25 (4%)	1	1/26 (3.8%)	1	0/23 (0%)	0
Abdominal distension	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Abdominal pain lower	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Frequent bowel movements	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Gastrooesophageal reflux disease	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Toothache	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Vomiting	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
General disorders
Fatigue	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	1/23 (4.3%)	1
Asthenia	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Early satiety	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Faecaloma	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Flatulence	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Influenza like illness	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Injection site pain	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Oedema peripheral	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Infections and infestations
COVID-19	0/26 (0%)	0	1/25 (4%)	1	1/26 (3.8%)	1	1/23 (4.3%)	1
Asymptomatic COVID-19	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	1/23 (4.3%)	1
Tooth infection	0/26 (0%)	0	1/25 (4%)	1	1/26 (3.8%)	1	0/23 (0%)	0
COVID-19 pneumonia	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Conjunctivitis	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Gastroenteritis	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Influenza	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Nasopharyngitis	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Soft tissue infection	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Tooth abscess	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Upper respiratory tract infection	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Urinary tract infection	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Injury, poisoning and procedural complications
Tooth fracture	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Investigations
Blood glucose increased	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Hepatic enzyme increased	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Magnetic resonance imaging abnormal	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Weight increased	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	1/26 (3.8%)	1	0/25 (0%)	0	2/26 (7.7%)	2	1/23 (4.3%)	1
Diabetes mellitus	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Hypoglycaemia	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Type 2 diabetes mellitus	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Bone pain	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Muscle spasms	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Pain in extremity	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Trigger finger	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Nervous system disorders
Headache	2/26 (7.7%)	2	1/25 (4%)	1	3/26 (11.5%)	3	2/23 (8.7%)	2
Dizziness	1/26 (3.8%)	1	1/25 (4%)	1	2/26 (7.7%)	2	0/23 (0%)	0
Lethargy	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Psychiatric disorders
Anxiety	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Insomnia	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Panic attack	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/26 (0%)	0	0/25 (0%)	0	0/26 (0%)	0	1/23 (4.3%)	1
Nasal congestion	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Rhinitis allergic	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Sinus congestion	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	0/26 (0%)	0	3/25 (12%)	3	3/26 (11.5%)	3	4/23 (17.4%)	4
Rash	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	1/23 (4.3%)	1
Erythema	0/26 (0%)	0	0/25 (0%)	0	1/26 (3.8%)	1	0/23 (0%)	0
Rash pruritic	0/26 (0%)	0	1/25 (4%)	1	0/26 (0%)	0	0/23 (0%)	0
Vascular disorders
Hypertension	1/26 (3.8%)	1	0/25 (0%)	0	0/26 (0%)	0	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.