A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01807026
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 6
• Duration (Months): 2
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief Summary

This study is being done for the following reasons:

To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses.

This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.

Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.

For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Healthy Volunteers	Drug: LY2886721; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Safety, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects and Patients Diagnosed With Alzheimer's Disease
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A: 70 mg LY2886721 Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.	Drug: LY2886721
Placebo Comparator: Cohort A: Placebo Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).	Drug: Placebo
Experimental: Cohort B: 70 mg LY2886721 Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Drug: LY2886721
Placebo Comparator: Cohort B: Placebo Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).	Drug: Placebo
Experimental: Cohort C: 280 mg LY2886721 Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.	Drug: LY2886721
Placebo Comparator: Cohort C: Placebo Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 [Predose through 96 hours after administration of study drug]

   AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.

2. Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 [Predose through 96 hours after administration of study drug]

   Cmax following administration of a single dose of 70 or 280 mg LY2886721.

3. Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 [Predose through 36 hours after administration of study drug]

   AUC0-∞ following administration of a single dose of 70 mg LY2886721.

4. Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 [Predose through 36 hours after administration of study drug]

   Cmax following administration of a single dose of 70 mg LY2886721.

5. Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 [Predose, up to 96 hours after administration of study drug]

   Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).

6. PD: Cnadir of CSF Aβ 1-40 [Predose up to 36 hours after administration of study drug]

   Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.

Secondary Outcome Measures

1. Cohort C: Mean QTcF Value at Cmax [Predose up to 48 hours after administration of study drug]

   The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.

• Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

• Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.

• Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.

• Mini Mental State Examination (MMSE) score of 16 through 28 at screening.

• Modified Hachinski Ischemia Scale (MHIS) score of <4.

• Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.

• If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Exclusion Criteria:

• Have an abnormality in the 12-lead electrocardiogram (ECG).

• Have abnormal blood pressure.

• Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

• Show evidence of hepatitis C and/or positive hepatitis C antibody.

• Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.

• Have chronic hepatic disease.

• Have evidence or history of significant active bleeding or a coagulation disorder.

• Cohort A: have any neurological disorders other than Alzheimer's disease.

• For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Salt Lake City	Utah	United States

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01807026
• Other Study ID Numbers: 15107; I4O-EW-BACX
• First Posted: Mar 8, 2013
• Last Update Posted: Jul 19, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

Participant Flow

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort A: Placebo	Cohort B: 70 mg LY2886721	Cohort B: Placebo	Cohort C: 280 mg LY2886721	Cohort C: Placebo
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721.	Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
Period Title: Overall Study
STARTED	10	2	10	2	9	3
Received at Least One Dose of Study Drug	10	2	10	2	9	3
COMPLETED	10	2	10	2	9	3
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort A: Placebo	Cohort B: 70 mg LY2886721	Cohort B: Placebo	Cohort C: 280 mg LY2886721	Cohort C: Placebo	Total
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.	Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).	Total of all reporting groups
Overall Participants	10	2	10	2	9	3	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.1 (12.6)	67.0 (18.4)	59.3 (6.8)	54.5 (3.5)	29.3 (11.3)	21.3 (0.6)	51.8 (20.7)
Sex: Female, Male (Count of Participants)
Female	6 60%	1 50%	5 50%	1 50%	1 11.1%	0 0%	14 38.9%
Male	4 40%	1 50%	5 50%	1 50%	8 88.9%	3 100%	22 61.1%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	1 2.8%
White	10 100%	2 100%	10 100%	2 100%	8 88.9%	3 100%	35 97.2%
Region of Enrollment (Count of Participants)
United States	10 100%	2 100%	10 100%	2 100%	9 100%	3 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721
Description	AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.
Time Frame	Predose through 96 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort B: 70 mg LY2886721	Cohort C: 280 mg LY2886721
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours/milliliter (ng*h/mL)]	2800 (25)	2580 (20)	10500 (22)

2. Primary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721
Description	Cmax following administration of a single dose of 70 or 280 mg LY2886721.
Time Frame	Predose through 96 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort B: 70 mg LY2886721	Cohort C: 280 mg LY2886721
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Measure Participants	10	10	9
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)]	183 (41)	180 (17)	888 (11)

3. Primary Outcome

Title	Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721
Description	AUC0-∞ following administration of a single dose of 70 mg LY2886721.
Time Frame	Predose through 36 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort B: 70 mg LY2886721
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]	458 (16)	410 (16)

4. Primary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721
Description	Cmax following administration of a single dose of 70 mg LY2886721.
Time Frame	Predose through 36 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort B: 70 mg LY2886721
Arm/Group Description	Participants with Alzheimer's received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
Measure Participants	10	10
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	24.0 (18)	24.4 (19)

5. Primary Outcome

Title	Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40
Description	Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).
Time Frame	Predose, up to 96 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 or placebo and had evaluable plasma Aβ 1-40 data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort A: Placebo	Cohort B: 70 mg LY2886721	Cohort C: 280 mg LY2886721	Cohorts B and C: Placebo
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.	Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
Measure Participants	10	2	10	9	5
Geometric Mean (Geometric Coefficient of Variation) [picograms/milliliter (pg/mL)]	22.2 (35.2)	140 (NA)	19.5 (11.9)	11.0 (42.2)	162 (7.39)

6. Primary Outcome

Title	PD: Cnadir of CSF Aβ 1-40
Description	Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.
Time Frame	Predose up to 36 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 at the 70-mg dose level or placebo and had evaluable CSF Aβ 1-40 data.

Arm/Group Title	Cohort A: 70 mg LY2886721	Cohort A: Placebo	Cohort B: 70 mg LY2886721	Cohort B: Placebo
Arm/Group Description	Participants with Alzheimer's received a single, 70-mg (1 capsule), oral dose of LY2886721.	Participants with Alzheimer's received a single, oral dose of LY2886721-matching placebo (1 capsule).	Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.	Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).
Measure Participants	10	2	10	2
Geometric Mean (Geometric Coefficient of Variation) [pg/mL]	7600 (30.7)	19500 (NA)	4480 (110)	12500 (NA)

7. Secondary Outcome

Title	Cohort C: Mean QTcF Value at Cmax
Description	The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.
Time Frame	Predose up to 48 hours after administration of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of LY2886721 at the 280-mg dose level and with evaluable mean QTcF data.

Arm/Group Title	Cohort C: 280 mg LY2886721
Arm/Group Description	Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Measure Participants	9
Mean (90% Confidence Interval) [milliseconds (ms)]	28.3

Adverse Events

Arm/Group Title	Cohort A: 70 mg LY2886721		Cohort A: Placebo		Cohort B: 70 mg LY2886721		Cohort B: Placebo		Cohort C: 280 mg LY2886721		Cohort C: Placebo
Arm/Group Description	Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.		Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule).		Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.		Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule).		Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.		Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules).
All Cause Mortality
	Cohort A: 70 mg LY2886721		Cohort A: Placebo		Cohort B: 70 mg LY2886721		Cohort B: Placebo		Cohort C: 280 mg LY2886721		Cohort C: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort A: 70 mg LY2886721		Cohort A: Placebo		Cohort B: 70 mg LY2886721		Cohort B: Placebo		Cohort C: 280 mg LY2886721		Cohort C: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/2 (0%)		0/10 (0%)		0/2 (0%)		0/9 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Cohort A: 70 mg LY2886721		Cohort A: Placebo		Cohort B: 70 mg LY2886721		Cohort B: Placebo		Cohort C: 280 mg LY2886721		Cohort C: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/10 (40%)		1/2 (50%)		8/10 (80%)		0/2 (0%)		1/9 (11.1%)		0/3 (0%)
Eye disorders
Photophobia	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Gastrointestinal disorders
Abdominal pain	1/10 (10%)	1	0/2 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Constipation	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Diarrhoea	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Nausea	0/10 (0%)	0	0/2 (0%)	0	3/10 (30%)	3	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Vomiting	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
General disorders
Fatigue	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Pain	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Investigations
Red blood cells csf positive	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/10 (0%)	0	0/2 (0%)	0	2/10 (20%)	2	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Muscle spasms	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Nervous system disorders
Dizziness	1/10 (10%)	1	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Headache	3/10 (30%)	3	1/2 (50%)	2	6/10 (60%)	7	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Migraine	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Presyncope	0/10 (0%)	0	0/2 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	1/9 (11.1%)	5	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
Cold sweat	0/10 (0%)	0	0/2 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0
Rash	0/10 (0%)	0	1/2 (50%)	1	0/10 (0%)	0	0/2 (0%)	0	0/9 (0%)	0	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.