NCT06028321 - Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV) | Biotech Hunter

Enrollment

51

Participants

Timeline

Start Date

November 26, 2021

Primary Completion Date

June 2, 2022

Study Completion Date

June 2, 2022

Conditions

Cachexia

Interventions

DRUG

Part 1 Group 1 Regime A (ACM-001.1)

"Drug: ACM-001.1 immediate release tablets for oral use and matching placebo, and pindolol tablets for oral use.~Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B."

DRUG

Part 1 Group 2 Regimen C (Pindolol)

Drug: Pindolol tablets for oral use.

DRUG

Part 2 Group D (Pindolol)

Drug: Pindolol tablets for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

DRUG

Part 2 Group E (ACM-001.1)

Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

DRUG

Part 2 Group F (ACM-001.1 )

Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

DRUG

Part 2 Group G (ACM-001.1)

Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

DRUG

Part 1 Group 1 Regimen B (Pindolol)

Drug: pindolol tablets for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.

OTHER

Part 1 Group 1 Regimen A (Placebo)

Placebo for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.

OTHER

Part 2 Group E (Placebo)

"Placebo for oral use. Subjects were dosed over a four day treatment period twice daily.~Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D."

OTHER

Part 2 Group F (Placebo)

Placebo for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

OTHER

Part 2 Group G ( Placebo)

Placebo for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.

Trial Locations (1)

NG11 9JS

Quotient Sciences Ltd, Ruddington