Trial Outcomes & Findings for Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers. (NCT NCT05930782)
NCT ID: NCT05930782
Last Updated: 2025-03-18
Results Overview
Blood samples are analysed for PQP concentrations at the indicated time points to determine the maximum observed plasma concentration (Cmax) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel Cmax is calculated as the (%) ratio of Cmax of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.
Results posted on
2025-03-18
Participant Flow
Participants were recruited between July 2023 and December 2023 from the local population residing within and surrounding areas of Bagamoyo town in Tanzania. The first participant was screened on 24 July 2023, the first was dosed on 14 August 2023, and the last was dosed on 06 December 2023.
Of 143 screened participants, 60 met inclusion criteria and were randomised to treatment. For Part 1 (Fasted) 24: Group 1 = 12 and Group 2 = 12. For Part 2 (Fed) 36: Group 3 = 12; Group 4 = 12 and Group 5 = 12
Participant milestones
| Measure |
Part 1 (Fasted) : Group 1 Piperaquine Hard Tablet
Participants received a single oral dose of Piperaquine hard tablet, 320mg, administered in a fasting condition of at least 10 hours. (N=12)
Piperaquine: Piperaquine tetraphosphate hard tablet 320 mg
|
Part 1 (Fasted): Group 2: Piperaquine Dispersible Granules
Participants received a single oral dose of Piperaquine dispersible granules 320mg in a fasting condition of at least 10 hours (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 3: High-fat Meal
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with a high-fat meal.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 4: Low-fat Meal Representative of African Diet.
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with a low-fat meal representative of African diet.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 5: Whole Milk 250 mL
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with 250mL of whole milk.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
|---|---|---|---|---|---|
|
Part 1: Fasted
STARTED
|
12
|
12
|
0
|
0
|
0
|
|
Part 1: Fasted
COMPLETED
|
12
|
12
|
0
|
0
|
0
|
|
Part 1: Fasted
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Fed
STARTED
|
0
|
0
|
12
|
12
|
12
|
|
Part 2: Fed
COMPLETED
|
0
|
0
|
12
|
12
|
12
|
|
Part 2: Fed
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
Baseline characteristics by cohort
| Measure |
Part 1 (Fasted) : Group 1 Piperaquine Hard Tablet
n=12 Participants
Participants received a single oral dose of Piperaquine hard tablet, 320mg, administered in a fasting condition of at least 10 hours. (N=12)
Piperaquine: Piperaquine tetraphosphate hard tablet 320 mg
|
Part 1 (Fasted): Group 2: Piperaquine Dispersible Granules
n=12 Participants
Participants received a single oral dose of Piperaquine dispersible granules 320mg in a fasting condition of at least 10 hours (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 3: High-fat Meal
n=12 Participants
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with a high-fat meal.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 4: Low-fat Meal Representative of African Diet.
n=12 Participants
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with a low-fat meal representative of African diet.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Part 2 Piperaquine Dispersible Granules (Fed): Group 5: Whole Milk 250 mL
n=12 Participants
Participants received a single oral dose of Piperaquine dispersible granules 320mg in fed conditions with 250mL of whole milk.
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
Part 1 (Fasted) · <=18 years
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Categorical
Part 1 (Fasted) · Between 18 and 65 years
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
24 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Categorical
Part 1 (Fasted) · >=65 years
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Categorical
Part 2 (Fed) · <=18 years
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Categorical
Part 2 (Fed) · Between 18 and 65 years
|
—
|
—
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
36 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Categorical
Part 2 (Fed) · >=65 years
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Continuous
Part 1 (Fasted)
|
29.1 years
STANDARD_DEVIATION 6.24 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
28.3 years
STANDARD_DEVIATION 4.74 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
28.7 years
STANDARD_DEVIATION 5.43 • n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Age, Continuous
Part 2 (Fed)
|
—
|
—
|
28.2 years
STANDARD_DEVIATION 7.02 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
28.6 years
STANDARD_DEVIATION 8.15 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
32.4 years
STANDARD_DEVIATION 10.14 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
29.7 years
STANDARD_DEVIATION 8.51 • n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Sex: Female, Male
Part 1 (Fasted) · Female
|
7 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
4 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
11 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Sex: Female, Male
Part 1 (Fasted) · Male
|
5 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
8 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
13 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Sex: Female, Male
Part 2 (Fed) · Female
|
—
|
—
|
6 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
7 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
6 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
19 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Sex: Female, Male
Part 2 (Fed) · Male
|
—
|
—
|
6 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
5 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
6 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
17 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · American Indian or Alaska Native
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · Asian
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · Black or African American
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
24 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · White
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · More than one race
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 1 (Fasted) · Unknown or Not Reported
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
0 Participants
n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · Asian
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · Black or African American
|
—
|
—
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
12 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
36 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · White
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · More than one race
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Race (NIH/OMB)
Part 2 (Fed) · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
0 Participants
n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Region of Enrollment
Tanzania
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
60 participants
n=60 Participants
|
|
Body Mass Index (BMI)
Part 1 (Fasted)
|
22.127 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.3784 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
21.355 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.0850 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
—
|
—
|
—
|
21.741 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.1884 • n=24 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
|
Body Mass Index (BMI)
Part 2 (Fed)
|
—
|
—
|
23.434 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.7032 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
22.853 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.3968 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
22.540 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.6998 • n=12 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
22.943 units on a scale (kg/m^2)
STANDARD_DEVIATION 3.5185 • n=36 Participants • Part 1 (Fasted) 24 participants: Group 1 = 12; Group 2 = 12 Part 2 (Fed) 36 Participants: Group 3 = 12; Group 4 = 12; Group 5 = 12
|
PRIMARY outcome
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.Population: The PK analysis set included all participants with sufficient plasma samples taken for at least one of the PK variables to be calculated, who received any study treatment and who experienced no protocol deviations with relevant impact on PK data.
Blood samples are analysed for PQP concentrations at the indicated time points to determine the maximum observed plasma concentration (Cmax) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel Cmax is calculated as the (%) ratio of Cmax of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Outcome measures
| Measure |
Part 1 Group 1 PQP Hard Tablet
n=12 Participants
Group 1: Piperaquine hard tablet, 320mg (administered in fasting condition of at least 10 hours) (N=12) Piperaquine Phosphate: PQP hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1: Group 2 PQP Dispersible Granules
n=12 Participants
Group 2: Piperaquine dispersible granules 320mg administered in fasting condition of at least 10 hours (N=12) Piperaquine Phosphate: PQP dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|
|
Relative Bioavailability (Frel) of the Maximum Observed Plasma Concentration (Cmax) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel Cmax).
|
37.4 ng/mL
Geometric Coefficient of Variation 71.46
|
27.6 ng/mL
Geometric Coefficient of Variation 61.64
|
PRIMARY outcome
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.Population: The PK analysis set included all participants who had sufficient plasma samples taken for at least one of the PK variables to be calculated and who received any study treatment and experienced no protocol deviations with relevant impact on PK data.
Blood samples are analysed for PQP concentrations at the indicated time points to calculate the area under the plasma concentration-time curve from time zero to 72 hours (AUC0-72h) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel AUC0-72h is calculated as the ratio of AUC0-72h of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Outcome measures
| Measure |
Part 1 Group 1 PQP Hard Tablet
n=12 Participants
Group 1: Piperaquine hard tablet, 320mg (administered in fasting condition of at least 10 hours) (N=12) Piperaquine Phosphate: PQP hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1: Group 2 PQP Dispersible Granules
n=12 Participants
Group 2: Piperaquine dispersible granules 320mg administered in fasting condition of at least 10 hours (N=12) Piperaquine Phosphate: PQP dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|
|
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 72h Hours (AUC0-72h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-72h).
|
809.7 ng*h/mL
Geometric Coefficient of Variation 42.77
|
610.6 ng*h/mL
Geometric Coefficient of Variation 43.41
|
PRIMARY outcome
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.Population: The PK analysis set included all participants who had sufficient plasma samples taken for at least one of the PK variables to be calculated and who received any study treatment and experienced no protocol deviations with relevant impact on PK data.
Blood samples are analysed for PQP concentrations at the indicated time points to calculate the area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel AUC0-t is calculated as the ratio of AUC0-t of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Outcome measures
| Measure |
Part 1 Group 1 PQP Hard Tablet
n=12 Participants
Group 1: Piperaquine hard tablet, 320mg (administered in fasting condition of at least 10 hours) (N=12) Piperaquine Phosphate: PQP hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1: Group 2 PQP Dispersible Granules
n=12 Participants
Group 2: Piperaquine dispersible granules 320mg administered in fasting condition of at least 10 hours (N=12) Piperaquine Phosphate: PQP dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|
|
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-t).
|
3267.1 ng*h/mL
Geometric Coefficient of Variation 31.74
|
2824.3 ng*h/mL
Geometric Coefficient of Variation 37.84
|
PRIMARY outcome
Timeframe: Plasma samples taken pre-dose -0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.Population: The PK analysis set included all participants who had sufficient plasma samples taken for at least one of the PK variables to be calculated and who received any study treatment and experienced no protocol deviations with relevant impact on PK data.
Blood samples are analysed for PQP concentrations at the indicated time points to calculate the area under the plasma concentration-time curve from time zero to 168 hours (AUC0-168h) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel AUC0-168h is calculated as the ratio of the AUC0-168h of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Outcome measures
| Measure |
Part 1 Group 1 PQP Hard Tablet
n=12 Participants
Group 1: Piperaquine hard tablet, 320mg (administered in fasting condition of at least 10 hours) (N=12) Piperaquine Phosphate: PQP hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1: Group 2 PQP Dispersible Granules
n=12 Participants
Group 2: Piperaquine dispersible granules 320mg administered in fasting condition of at least 10 hours (N=12) Piperaquine Phosphate: PQP dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|
|
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 168 Hours (AUC0-168h) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-168h.
|
1373.1 ng*h/mL
Geometric Coefficient of Variation 36.53
|
1066.5 ng*h/mL
Geometric Coefficient of Variation 42.2
|
PRIMARY outcome
Timeframe: Plasma samples taken pre-dose 0.5 hours, then 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, Day 5, Day 8, Day 15, Day 22 and Day 30 post-dose.Population: The PK analysis set included all participants who had sufficient plasma samples taken for at least one of the PK variables to be calculated and who received any study treatment and experienced no protocol deviations with relevant impact on PK data. The AUC0-inf was reliably determined (extrapolation to infinity was \<20%) for only one participant in the Test group and two participants in the Reference group/
Blood samples are analysed for PQP concentrations at the indicated time points to calculate the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for PQP dispersible granule (test) and PQP hard tablet (reference) in the fasted state. Pharmacokinetic parameters are determined using standard non-compartmental analysis. Frel AUC0-∞ is calculated as the ratio of the AUC0-∞ of the PQP dispersible granule compared to the PQP hard tablet in the fasted state.
Outcome measures
| Measure |
Part 1 Group 1 PQP Hard Tablet
n=2 Participants
Group 1: Piperaquine hard tablet, 320mg (administered in fasting condition of at least 10 hours) (N=12) Piperaquine Phosphate: PQP hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1: Group 2 PQP Dispersible Granules
n=1 Participants
Group 2: Piperaquine dispersible granules 320mg administered in fasting condition of at least 10 hours (N=12) Piperaquine Phosphate: PQP dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|
|
Relative Bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of the PQP Dispersible Granule Compared to the PQP Hard Tablet in the Fasted State (Frel AUC0-∞).
|
4597.8 ng*h/mL
Geometric Coefficient of Variation 29.25
|
2539.7 ng*h/mL
|
Adverse Events
Part 1 (Fasted): Group 1: Piperaquine Hard Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (Fasted): Group 2: Piperaquine Dispersible Granules
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 (Fed): Group 3: Piperaquine Dispersible Granules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 (Fed): Group 4: Piperaquine Dispersible Granules
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 (Fed): Group 5: Piperaquine Dispersible Granules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 (Fasted): Group 1: Piperaquine Hard Tablets
n=12 participants at risk
Participants received a single oral dose of Piperaquine hard tablets 320mg (administered in fasting condition of at least 10 hours) (N=12)
Piperaquine: Piperaquine tetraphosphate hard tablets 320mg
Piperaquine Tetraphosphate uncoated tablets: Piperaquine tetraphosphate hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water
|
Part 1 (Fasted): Group 2: Piperaquine Dispersible Granules
n=12 participants at risk
Participants received a single oral dose of Piperaquine dispersible granule 320mg (administered in fasting condition of at least 10 hours) (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
Piperaquine Tetraphosphate dispersible granules: Piperaquine tetraphosphate dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
Part 2 (Fed): Group 3: Piperaquine Dispersible Granules
n=12 participants at risk
Participants received a single oral dose of Piperaquine dispersible granule 320mg administered with a high-fat meal (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
Piperaquine Tetraphosphate dispersible granules: Piperaquine tetraphosphate dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
Part 2 (Fed): Group 4: Piperaquine Dispersible Granules
n=12 participants at risk
Participants received a single oral dose of Piperaquine dispersible granule 320mg administered with a low-fat meal representative of African diet. (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
Piperaquine Tetraphosphate dispersible granules: Piperaquine tetraphosphate dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
Part 2 (Fed): Group 5: Piperaquine Dispersible Granules
n=12 participants at risk
Participants received a single oral dose of Piperaquine dispersible granule 320mg administered with whole milk (250ml) (N=12)
Piperaquine: Piperaquine tetraphosphate dispersible granules 320mg
Piperaquine Tetraphosphate dispersible granules: Piperaquine tetraphosphate dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
8.3%
1/12 • Number of events 1 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
|
Investigations
Heart rate increased
|
8.3%
1/12 • Number of events 1 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
8.3%
1/12 • Number of events 1 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
0.00%
0/12 • The investigator was responsible for documenting and reporting all AEs occurring in the clinical trial. The period of observation for the collection of AEs extended from the time of signing consent to the final visit, a maximum of 75 days. All AEs were recorded until the end of the study. All SAEs which came to the attention of the Investigator within 30 days from the end of the study treatment were also recorded.
* Pre-treatment adverse event: AEs between informed consent and Investigational Medicinal Product administration. * Adverse Event: Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to it. * TEAEs: An event that emerges during treatment, have been absent pre-treatment or worsens relative to the pre-treatment state.
|
Additional Information
Dr Anne Claire Marrast
MMV Medicines for Malaria Venture
Phone: +41 22 555 03 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place