A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

• Sponsor: Janssen Pharmaceutical K.K. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02993250
• Collaborator: (none)
• Enrollment: 33
• Locations: 14
• Arms: 2
• Actual Duration (Months): 16.5
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve
• Actual Study Start Date: Dec 21, 2016
• Actual Primary Completion Date: May 7, 2018
• Actual Study Completion Date: May 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 (Chronic Hepatitis C Without Cirrhosis) Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.	Drug: AL-335; Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: JNJ-64146212 ; Drug: Odalasvir (ODV); Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: JNJ-64289901 ; Drug: Simeprevir (SMV); Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: TMC435
Experimental: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).	Drug: AL-335; Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: JNJ-64146212 ; Drug: Odalasvir (ODV); Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: JNJ-64289901 ; Drug: Simeprevir (SMV); Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Other Names: TMC435

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)]

   An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Secondary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment [Week 4 (follow-up phase)]

   SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).

2. Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment [Week 12 (follow-up phase)]

   SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.

3. Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment [Week 24 (follow-up phase)]

   SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.

4. Percentage of Participants With Viral Relapse [End of treatment up to Week 24 (follow up phase)]

   Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.

5. Percentage of Participants With On-treatment Failure [EOT up to Week 12 (follow up phase)]

   On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.

6. Percentage of Participants With On-treatment Virologic Response [Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)]

   Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.

7. Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ [EOT up to Week 24 (follow up phase)]

   Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic hepatitis C virus (HCV) infection

• All participants must have HCV genotype 1 or 2 infection, determined at screening

• HCV ribonucleic acid (RNA) plasma levels greater than or equal to (>=)10,000 international units per Milliliter (IU/mL), determined at screening

• Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed

• Participants without cirrhosis or with compensated cirrhosis

Exclusion Criteria:

• Infection with HCV genotype - 3, 4, 5, or 6

• Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)

• Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free

• Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator

• Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Amagasaki-shi		Japan
2		Bunkyo-ku		Japan
3		Hiroshima-shi		Japan
4		Kagoshima-shi		Japan
5		Kurume-shi		Japan
6		Musashino-shi		Japan
7		Nagoya-shi		Japan
8		Omura-shi		Japan
9		Osaka-shi		Japan
10		Saitama		Japan
11		Sakai-shi		Japan
12		Sapporo-shi		Japan
13		Suita-shi		Japan
14		Yokohama-shi		Japan

Sponsors and Collaborators

• Janssen Pharmaceutical K.K.

Investigators

• Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 8, 2018
• Study Protocol - Jul 27, 2017

More Information

Publications

None provided.

• Responsible Party: Janssen Pharmaceutical K.K.
• ClinicalTrials.gov Identifier: NCT02993250
• Other Study ID Numbers: CR108264; 64294178HPC2003
• First Posted: Dec 15, 2016
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Simeprevir; Odalasvir

Study Results

Participant Flow

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Period Title: Overall Study
STARTED	22	11
COMPLETED	22	10
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis	Total
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.	Total of all reporting groups
Overall Participants	22	11	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (11.1)	54.9 (6.76)	57.8 (9.98)
Sex: Female, Male (Count of Participants)
Female	17 77.3%	4 36.4%	21 63.6%
Male	5 22.7%	7 63.6%	12 36.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	22 100%	11 100%	33 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	22 100%	11 100%	33 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Japan	22 100%	11 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame	Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)

Outcome Measure Data

Analysis Population Description

The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Number [participants]	15 68.2%	9 81.8%

2. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment
Description	SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).
Time Frame	Week 4 (follow-up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Number (95% Confidence Interval) [Percentage of participants]	100 454.5%	100 909.1%

3. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment
Description	SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.
Time Frame	Week 12 (follow-up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Number (95% Confidence Interval) [Percentage of participants]	100 454.5%	100 909.1%

4. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment
Description	SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.
Time Frame	Week 24 (follow-up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	10
Number (95% Confidence Interval) [Percentage of participants]	100 454.5%	90.9 826.4%

5. Secondary Outcome

Title	Percentage of Participants With Viral Relapse
Description	Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
Time Frame	End of treatment up to Week 24 (follow up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)] and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Number [Percentage of participants]	0 0%	0 0%

6. Secondary Outcome

Title	Percentage of Participants With On-treatment Failure
Description	On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.
Time Frame	EOT up to Week 12 (follow up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Number [Percentage of Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Response
Description	Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.
Time Frame	Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Day 2: < 15 IU/mL not detected	4.5 20.5%	0 0%
Day 3: < 15 IU/mL not detected	4.5 20.5%	0 0%
Week 1: < 15 IU/mL not detected	4.5 20.5%	18.2 165.5%
Week 2: < 15 IU/mL not detected	22.7 103.2%	45.5 413.6%
Week 3: < 15 IU/mL not detected	54.5 247.7%	63.6 578.2%
week 4: < 15 IU/mL not detected	72.7 330.5%	72.7 660.9%
Week 6: < 15 IU/mL not detected	90.9 413.2%	100 909.1%
Week 8: < 15 IU/mL not detected	100 454.5%	100 909.1%
Week 10: < 15 IU/mL not detected	100 454.5%
Week 12: < 15 IU/mL not detected	100 454.5%

8. Secondary Outcome

Title	Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ
Description	Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.
Time Frame	EOT up to Week 24 (follow up phase)

Outcome Measure Data

Analysis Population Description

Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.

Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis	Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.	Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
Measure Participants	22	11
Mean (Standard Deviation) [Days]	19.0 (1.68)	18.6 (3.86)

Adverse Events

Time Frame	Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Adverse Event Reporting Description	Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].
Arm/Group Title	Cohort 1: Chronic Hepatitis C Without Cirrhosis		Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
Arm/Group Description	Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.		Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.
All Cause Mortality
	Cohort 1: Chronic Hepatitis C Without Cirrhosis		Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/11 (0%)
Serious Adverse Events
	Cohort 1: Chronic Hepatitis C Without Cirrhosis		Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		1/11 (9.1%)
Eye disorders
Cataract	0/22 (0%)		1/11 (9.1%)
Other (Not Including Serious) Adverse Events
	Cohort 1: Chronic Hepatitis C Without Cirrhosis		Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/22 (68.2%)		9/11 (81.8%)
Cardiac disorders
Atrioventricular Block First Degree	2/22 (9.1%)		1/11 (9.1%)
Supraventricular Extrasystoles	0/22 (0%)		1/11 (9.1%)
Eye disorders
Cataract	0/22 (0%)		1/11 (9.1%)
Eye Discharge	0/22 (0%)		1/11 (9.1%)
Gastrointestinal disorders
Abdominal Pain Upper	2/22 (9.1%)		0/11 (0%)
Diarrhoea	3/22 (13.6%)		0/11 (0%)
Gastritis	0/22 (0%)		2/11 (18.2%)
Gastrointestinal Motility Disorder	0/22 (0%)		1/11 (9.1%)
General disorders
Malaise	2/22 (9.1%)		0/11 (0%)
Infections and infestations
Nasopharyngitis	0/22 (0%)		1/11 (9.1%)
Oral Herpes	0/22 (0%)		1/11 (9.1%)
Viral Upper Respiratory Tract Infection	1/22 (4.5%)		4/11 (36.4%)
Investigations
Alanine Aminotransferase Increased	2/22 (9.1%)		2/11 (18.2%)
Aspartate Aminotransferase Increased	2/22 (9.1%)		2/11 (18.2%)
Blood Cholesterol Increased	0/22 (0%)		1/11 (9.1%)
Musculoskeletal and connective tissue disorders
Neck Pain	1/22 (4.5%)		1/11 (9.1%)
Pain in Extremity	0/22 (0%)		1/11 (9.1%)
Tenosynovitis	0/22 (0%)		1/11 (9.1%)
Nervous system disorders
Headache	3/22 (13.6%)		2/11 (18.2%)
Skin and subcutaneous tissue disorders
Eczema	0/22 (0%)		1/11 (9.1%)

Limitations/Caveats

As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.

More Information

Certain Agreements

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

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.