A safety, tolerability, and pharmacokinetic study of single and multiple ascending doses of LY3322207 in healthy subjects and subjects with hypertension on ACE I/ARB therapy.

A safety, tolerability, and pharmacokinetic study of single and multiple ascending doses of LY3322207 in healthy subjects and subjects with hypertension on ACE I/ARB therapy. - SAD MAD Urocortin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45832

Enrollment

Registered

2018-06-28

Start date

2018-07-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Part A: Group 1

0.1 mg LY3322207 or placebo once Group 2

0.5 mg LY3322207 or placebo once Group 3

2.5 mg LY3322207 or placebo once Group 4

10 mg LY3322207 or placebo once Group 5

20 mg LY3322207 or placebo once Group 6

40 mg LY3322207 or placebo once Part B: Group 1

0.5 mg LY3322207 or placebo once a week for 6 weeks Group 2

2.5 mg LY3322207 or placebo once a week for 6 weeks Group 3

10 mg LY3322207 or placebo once a week for 6 weeks Group 4

20 mg LY3322207 or placebo once a week for 6 weeks Part C: Group 1

20 mg LY3322207 or placebo once a week for 6 weeks

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female (sterilized or post-menopausal) 18 - 65 jaar age BMI 18.0 - 30.0 kilograms/meter2 non smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
(Part A - SAD) To evaluate safety and tolerability of LY3322207 in healthy subjects following a single SC dose. (Part B - MAD) To evaluate safety and tolerability of LY3322207 in healthy subjects following multiple SC doses. (Part C) To evaluate safety and tolerability of LY3322207 in subjects with hypertension (on ACE-I/ARB therapy).	—

Secondary

Measure	Time frame
(Part A - SAD) To evaluate the pharmacokinetics of LY3322207 in healthy subjects following a single SC dose To evaluate the effects of LY3322207 on blood pressure in healthy subjects following a single SC dose To evaluate the effects of LY3322207 on heart rate in healthy subjects following a single SC dose (Part B - MAD) To evaluate the pharmacokinetics of LY3322207 in healthy subjects following multiple SC doses To evaluate the effects of LY3322207 on blood pressure in healthy subjects following multiple SC doses To evaluate the effects of LY3322207 on heart rate in healthy subjects following multiple SC doses (Part C) To evaluate the pharmacokinetics of LY3322207 in subjects with hypertension (on ACE-I/ARB therapy). To evaluate the effects of LY3322207 on blood pressure in subjects with hypertension (on ACE-I/ARB therapy). To evaluate the effects of LY3322207 on heart rate in subjects with hypertension (on ACE-I/ARB therapy).	—

Measure

Time frame

(Part A - SAD) To evaluate the pharmacokinetics of LY3322207 in healthy subjects following a single SC dose To evaluate the effects of LY3322207 on blood pressure in healthy subjects following a single SC dose To evaluate the effects of LY3322207 on heart rate in healthy subjects following a single SC dose (Part B - MAD) To evaluate the pharmacokinetics of LY3322207 in healthy subjects following multiple SC doses To evaluate the effects of LY3322207 on blood pressure in healthy subjects following multiple SC doses To evaluate the effects of LY3322207 on heart rate in healthy subjects following multiple SC doses (Part C) To evaluate the pharmacokinetics of LY3322207 in subjects with hypertension (on ACE-I/ARB therapy). To evaluate the effects of LY3322207 on blood pressure in subjects with hypertension (on ACE-I/ARB therapy). To evaluate the effects of LY3322207 on heart rate in subjects with hypertension (on ACE-I/ARB therapy).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)