Trial Outcomes & Findings for Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions (NCT NCT04411940)

NCT ID: NCT04411940

Last Updated: 2022-06-08

Results Overview

The maximum observed concentration of haloperidol as measured by bioanalysis of the blood plasma is referred to as the Cmax.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose
• Results posted on: 2022-06-08

Participant Flow

64 subjects participated in the screening phase of the study.

32 subjects were enrolled in the study. 29 were excluded from the study. 3 subjects were kept as standbys.

Participant milestones

Measure	Reference Product (Treatment A), Then Test Product (Treatment B) Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, United States Pharmacopeia (USP) (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with Investigational Medicinal Product (IMP) and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet Then Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B), Then Reference Product (Treatment A) Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet Then Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet
Treatment Period 1 (8 Days) STARTED	16	16
Treatment Period 1 (8 Days) COMPLETED	16	16
Treatment Period 1 (8 Days) NOT COMPLETED	0	0
Washout Period (14 Days) STARTED	16	16
Washout Period (14 Days) COMPLETED	16	16
Washout Period (14 Days) NOT COMPLETED	0	0
Treatment Period 2 (8 Days) STARTED	16	16
Treatment Period 2 (8 Days) COMPLETED	16	16
Treatment Period 2 (8 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions

Baseline characteristics by cohort

Measure	Sequence AB n=16 Participants Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet	Sequence BA n=16 Participants Treatment B: Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet Treatment A: Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Total n=32 Participants Total of all reporting groups
Age, Continuous	29.1 Years STANDARD_DEVIATION 7.64 • n=5 Participants	28.9 Years STANDARD_DEVIATION 8.37 • n=7 Participants	29.0 Years STANDARD_DEVIATION 7.88 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Height	165.92 cm STANDARD_DEVIATION 8.67 • n=5 Participants	170.78 cm STANDARD_DEVIATION 7.91 • n=7 Participants	168.35 cm STANDARD_DEVIATION 8.53 • n=5 Participants
Weight	64.15 kg STANDARD_DEVIATION 11.00 • n=5 Participants	67.12 kg STANDARD_DEVIATION 12.30 • n=7 Participants	65.64 kg STANDARD_DEVIATION 11.58 • n=5 Participants
BMI	23.18 kg/m^2 STANDARD_DEVIATION 2.50 • n=5 Participants	22.97 kg/m^2 STANDARD_DEVIATION 3.45 • n=7 Participants	23.08 kg/m^2 STANDARD_DEVIATION 2.96 • n=5 Participants

PRIMARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

The maximum observed concentration of haloperidol as measured by bioanalysis of the blood plasma is referred to as the Cmax.

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Concentration Maximum (Cmax)	0.9092 ng/ml Standard Deviation 0.4395	0.8711 ng/ml Standard Deviation 0.4566

PRIMARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

Area under the plasma concentration versus time curve from time zero to t, where t is the time of the timepoint of the last quantifiable concentration of haloperidol in the blood plasma. The curve is constructed by plotting the concentration of haloperidol in the blood plasma against the time for each blood sample.

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Area Under the Curve (0-t) (AUC(0-t))	20.10 h*ng/ml Standard Deviation 7.263	19.89 h*ng/ml Standard Deviation 7.443

PRIMARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

Area under the plasma concentration versus time curve from time zero to ∞, where ∞ is the timepoint of the last quantifiable concentration of haloperidol in the blood plasma, plus it's elimination rate constant. AUC(0-∞) = AUC(0-t) + AUC(t-∞).

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Area Under the Curve(0-∞) (AUC(0-∞))	22.16 h*ng/ml Standard Deviation 7.586	22.28 h*ng/ml Standard Deviation 8.040

SECONDARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

The timepoint at which the maximum concentration of haloperidol as measured by bioanalysis of the blood plasma is observed.

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Time to Maximum Concentration (Tmax)	4.394 Hours Standard Deviation 0.959	4.406 Hours Standard Deviation 1.096

SECONDARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a blood plasma concentration versus time curve.

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Terminal Elimination Rate Constant (λz)	0.01194 1/h Standard Deviation 0.003043	0.01124 1/h Standard Deviation 0.002704

SECONDARY outcome

Timeframe: pre-dose (0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16, 24, 30, 36, 48, 72, 96, 120, 144, 168, 192 hours post dose

The apparent terminal elimination half-life (t½) is defined as the time necessary for the concentration of a drug to decrease by a factor of one-half in the terminal phase.

Outcome measures

Measure	Reference Product (Treatment A) n=32 Participants Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 Participants Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Apparent Terminal Elimination Half-Life (t½)	62.31 Hours Standard Deviation 18.71	65.99 Hours Standard Deviation 19.27

Adverse Events

Reference Product (Treatment A)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Test Product (Treatment B)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Reference Product (Treatment A) n=32 participants at risk Subjects received Haloperidol Tablets 2 mg Reference Product (Mylan Pharmaceuticals Inc.). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Mylan Pharmaceuticals Inc.: single dose, 2 mg Haloperidol tablet	Test Product (Treatment B) n=32 participants at risk Subjects received Haloperidol Tablets 2 mg Test Product (Cycle Pharmaceuticals Ltd). Subjects also received as pre-medication Benztropine Mesylate Tablets, USP (1 mg every 10 to 12 hours), beginning 4 to 6 hours before dosing with IMP and continued for a total of 4 doses. Haloperidol Tablets, Cycle Pharmaceuticals Ltd: single dose, 2 mg Haloperidol tablet
Respiratory, thoracic and mediastinal disorders Dry Throat	40.6% 13/32 • Number of events 13 • Adverse events data was collected for the duration of the study (24 days).	43.8% 14/32 • Number of events 14 • Adverse events data was collected for the duration of the study (24 days).
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Respiratory, thoracic and mediastinal disorders Dysphonia	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Dry Mouth	28.1% 9/32 • Number of events 9 • Adverse events data was collected for the duration of the study (24 days).	28.1% 9/32 • Number of events 10 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Lip Dry	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	6.2% 2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Abdominal Pain	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Diarrhoea	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Epigastric Discomfort	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Respiratory, thoracic and mediastinal disorders Nausea	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Gastrointestinal disorders Salivary Hypersecretion	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Nervous system disorders Headache	31.2% 10/32 • Number of events 10 • Adverse events data was collected for the duration of the study (24 days).	21.9% 7/32 • Number of events 9 • Adverse events data was collected for the duration of the study (24 days).
Nervous system disorders Dizziness	6.2% 2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Nervous system disorders Somnolence	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Nervous system disorders Disturbance in Attention	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Nervous system disorders Migraine	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Infections and infestations Conjunctivitis	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Infections and infestations Influenza	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Infections and infestations Nasopharyngitis	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Infections and infestations Rhinitis	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Infections and infestations Upper Respiratory Tract Infection	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Eye disorders Vision Blurred	6.2% 2/32 • Number of events 2 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Musculoskeletal and connective tissue disorders Pain in Jaw	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
General disorders Chest Pain	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Psychiatric disorders Insomnia	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).
Skin and subcutaneous tissue disorders Skin Lesion Inflammation	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).
Vascular disorders Phlebitis	0.00% 0/32 • Adverse events data was collected for the duration of the study (24 days).	3.1% 1/32 • Number of events 1 • Adverse events data was collected for the duration of the study (24 days).

Additional Information

Head of Global Regulatory Affairs & Clinical Development

Cycle Pharmaceuticals

Phone: +441223803635

Email: claudia.percivalle@cyclepharma.com

Results disclosure agreements

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