A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body

NCT04232839 | Terminated Phase 1 Results

• 2 other identifiers: 1371-00222019-003424-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

  Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.

Study Arms (10)

T3-R1-T1-T4-T2-T5 (sequence I+T5)

EXPERIMENTAL

Sequence I+T5, with treatments in the following order: T3-R1-T1-T4-T2-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T3-R1-T1-T4-T2-T6 (sequence I+T6)

EXPERIMENTAL

Sequence I+T6, with treatments in the following order: T3-R1-T1-T4-T2-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T2-T1-T3-R1-T4-T5 (sequence II+T5)

EXPERIMENTAL

Sequence II+T5, with treatments in the following order: T2-T1-T3-R1-T4-T5with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T2-T1-T3-R1-T4-T6 (sequence II+T6)

EXPERIMENTAL

Sequence II+T6, with treatments in the following order: T2-T1-T3-R1-T4-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T4-T3-R1-T2-T1-T5 (sequence III+T5)

EXPERIMENTAL

Sequence III+T5, with treatments in the following order: T4-T3-R1-T2-T1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T4-T3-R1-T2-T1-T6 (sequence III+T6)

EXPERIMENTAL

Sequence III+T6, with treatments in the following order: T4-T3-R1-T2-T1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T1-T4-T2-T3-R1-T5 (sequence IV+T5)

EXPERIMENTAL

Sequence IV+T5, with treatments in the following order: T1-T4-T2-T3-R1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

T1-T4-T2-T3-R1-T6 (sequence IV+T6)

EXPERIMENTAL

Sequence IV+T6, with treatments in the following order: T1-T4-T2-T3-R1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

R1-T2-T4-T1-T3-T5 (sequence V+T5)

EXPERIMENTAL

Sequence V+T5, with treatments in the following order: R1-T2-T4-T1-T3-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

R1-T2-T4-T1-T3-T6 (sequence V+T6)

EXPERIMENTAL

Sequence V+T6, with treatments in the following order: R1-T2-T4-T1-T3-T6with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

Interventions

BI 894416 Reference Formulation DRUG

R1 - 60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 mL of water after an overnight fast of at least 10 hours.

R1-T2-T4-T1-T3-T5 (sequence V+T5); R1-T2-T4-T1-T3-T6 (sequence V+T6); T1-T4-T2-T3-R1-T5 (sequence IV+T5); T1-T4-T2-T3-R1-T6 (sequence IV+T6); T2-T1-T3-R1-T4-T5 (sequence II+T5); T2-T1-T3-R1-T4-T6 (sequence II+T6); T3-R1-T1-T4-T2-T5 (sequence I+T5); T3-R1-T1-T4-T2-T6 (sequence I+T6); T4-T3-R1-T2-T1-T5 (sequence III+T5); T4-T3-R1-T2-T1-T6 (sequence III+T6)

BI 894416 Formulation A2 DRUG

T1 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.

R1-T2-T4-T1-T3-T5 (sequence V+T5); R1-T2-T4-T1-T3-T6 (sequence V+T6); T1-T4-T2-T3-R1-T5 (sequence IV+T5); T1-T4-T2-T3-R1-T6 (sequence IV+T6); T2-T1-T3-R1-T4-T5 (sequence II+T5); T2-T1-T3-R1-T4-T6 (sequence II+T6); T3-R1-T1-T4-T2-T5 (sequence I+T5); T3-R1-T1-T4-T2-T6 (sequence I+T6); T4-T3-R1-T2-T1-T5 (sequence III+T5); T4-T3-R1-T2-T1-T6 (sequence III+T6)

BI 894416 Formulation C2 DRUG

T2 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T5 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.

R1-T2-T4-T1-T3-T5 (sequence V+T5); R1-T2-T4-T1-T3-T6 (sequence V+T6); T1-T4-T2-T3-R1-T5 (sequence IV+T5); T1-T4-T2-T3-R1-T6 (sequence IV+T6); T2-T1-T3-R1-T4-T5 (sequence II+T5); T2-T1-T3-R1-T4-T6 (sequence II+T6); T3-R1-T1-T4-T2-T5 (sequence I+T5); T3-R1-T1-T4-T2-T6 (sequence I+T6); T4-T3-R1-T2-T1-T5 (sequence III+T5); T4-T3-R1-T2-T1-T6 (sequence III+T6)

BI 894416 Formulation D2 DRUG

T3 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation D2, extended release (ER) capsule (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.

R1-T2-T4-T1-T3-T5 (sequence V+T5); R1-T2-T4-T1-T3-T6 (sequence V+T6); T1-T4-T2-T3-R1-T5 (sequence IV+T5); T1-T4-T2-T3-R1-T6 (sequence IV+T6); T2-T1-T3-R1-T4-T5 (sequence II+T5); T2-T1-T3-R1-T4-T6 (sequence II+T6); T3-R1-T1-T4-T2-T5 (sequence I+T5); T3-R1-T1-T4-T2-T6 (sequence I+T6); T4-T3-R1-T2-T1-T5 (sequence III+T5); T4-T3-R1-T2-T1-T6 (sequence III+T6)

BI 894416 Formulation F2 DRUG

T4 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T6 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.

R1-T2-T4-T1-T3-T5 (sequence V+T5); R1-T2-T4-T1-T3-T6 (sequence V+T6); T1-T4-T2-T3-R1-T5 (sequence IV+T5); T1-T4-T2-T3-R1-T6 (sequence IV+T6); T2-T1-T3-R1-T4-T5 (sequence II+T5); T2-T1-T3-R1-T4-T6 (sequence II+T6); T3-R1-T1-T4-T2-T5 (sequence I+T5); T3-R1-T1-T4-T2-T6 (sequence I+T6); T4-T3-R1-T2-T1-T5 (sequence III+T5); T4-T3-R1-T2-T1-T6 (sequence III+T6)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive) at the time of signing informed consent
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) as measured at screening
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
• Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
• Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
• Condoms plus surgically sterilised partner (including hysterectomy) or
• Condoms plus intrauterine device or
• Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner (both, male and female) to the study drug via seminal fluid. Male subjects should use a condom throughout the study and for 30 days after last Investigational Medicinal Product (IMP) administration. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration

You may not qualify if:

• Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR), Electrocardiogram (ECG), physical and neurological examination) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients). Inactive hayfever is permitted.
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 90 days of planned first administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker (unless the subject quit smoking for at least 3 months prior to first planned administration of trial medication) as demonstrated by a positive urine cotinine test; this includes also the use of e-cigarettes and nicotine replacement products
• Alcohol abuse (consumption of more than 21 units per week) or positive alcohol breath test
• Drug abuse or positive drug screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: February 25, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)